louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00160888: Vasoreactivity in Carriers of Genetic Polymorphisms
Official title: Endothelium-Dependent Vasoreactivity in Nitric Oxide Synthase Gene (Glu298Asp) Polymorphism: Studies in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: The objective of the study is to assess the impact of genetic variation (especially polymorphisms of the gene coding endothelial nitric oxide synthase (eNOS) and the bradykinin B2 receptor gene) on venous and arterial responsiveness to vasodilators in healthy individuals without cardiovascular risk factors.

Detailed description: Study I: Using the dorsal hand vein compliance technique dose-response curves to bradykinin and sodium nitroprusside will be obtained in healthy volunteers during preconstriction with phenylephrine and after pretreatment with a single dose of 500 mg i.v. acetylsalicylic acid.

Study II: Using venous occlusion plethysmography dose-response curves to acetylcholine, sodium nitroprusside and L-NG-monomethyl-arginine (L-NMMA) will be obtained in healthy volunteers pretreated with a single dose of 500mg i.v. acetylsalicylic acid.

Eligibility criteria: Inclusion Criteria:

* age: 18 - 70
* gender: male
* good state of health

Exclusion Criteria:

* known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, homocysteinemia)
* regular medication and/or treatment with drugs within the last 4-6 weeks (exclusion has to be decided in each case)
* acute or chronic illness
* methylxanthines and alcohol during 12 hours before the study
* nicotine during 1 year before the study
* drug and/or alcohol abuse
* pregnancy or lactation

Primary outcomes:
measure: Study I: Venous responsiveness assessed by dorsal hand vein compliance technique
measure: Study II: Forearm blood flow assessed by venous occlusion plethysmography
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Dept. of Internal Medicine VI
state: Baden-Württemberg
Study officials:
affiliation: Dept. of Internal Medicine VI, University of Heidelberg
name: Walter E Haefeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fricker R, Hesse C, Weiss J, Tayrouz Y, Hoffmann MM, Unnebrink K, Mansmann U, Haefeli WE. Endothelial venodilator response in carriers of genetic polymorphisms involved in NO synthesis and degradation. Br J Clin Pharmacol. 2004 Aug;58(2):169-77. doi: 10.1111/j.1365-2125.2004.02130.x.
Clinical trial NCT02714088: The Effect of Novel High-intensity Interval Training on Physical Fitness in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-intensity Interval Training
Keywords: High-intensity interval training
Functional fitness
Quality of life
Older adults
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: High-intensity interval training (HIT) has been demonstrated to be an effective strategy to improve markers of health and fitness across a wide range of healthy and clinical populations. Currently however, there is only limited evidence which has examined the effectiveness of HIT in older adults (\>50 years). HIT is an appealing strategy in this group as it has the potential to impact both cardiorespiratory and muscular fitness, which both play an important role in maintaining functional fitness and quality of life in a time-efficient manner. Developing an understanding of novel strategies for delivering this type of exercise training may ultimately provide a viable alternative to traditional modes of exercise training for a broader range of participants. As such, the purpose of this study is to evaluate the effects of a novel, high-intensity interval training exercise protocol to improve physical fitness in adults aged over 50 years. This research also aims to evaluate if this type of training intervention is feasible in this population, through analysis of adherence and intervention fidelity.


Eligibility criteria: Inclusion Criteria:

1. Must be aged 50-85 years
2. Must be able to provide informed consent to participate
3. Must be free from all exclusion criteria

Exclusion Criteria:

1. Symptoms of or known presence of heart disease of major atherosclerotic cardiovascular disease
2. Early family history of sudden cardiac death
3. Condition or injury or co-morbidity affecting the ability to undertake exercise
4. Diabetes mellitus
5. Pregnancy or likelihood of pregnancy

Primary outcomes:
measure: Change in lower body muscular power
timeFrame: Baseline and following exercise training (12 weeks)
measure: Change in Aerobic fitness
timeFrame: Baseline and following exercise training (12 weeks)
measure: Change in upper extremity muscular strength
timeFrame: Baseline and following exercise training (12 weeks)
measure: Change in quality of life
timeFrame: Baseline and following exercise training (12 weeks)
Secondary outcomes:
Other outcomes:
measure: Heart rate during high-intensity interval training exercise sessions
timeFrame: Up to 12 weeks
measure: Rating of perceived exertion (RPE) during high-intensity interval training exercise sessions
timeFrame: Up to 12 weeks
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University
state: Tees Valley
Study officials:
References:
Clinical trial NCT04548388: EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS
Official title: EFFECT of WHOLE BODY VIBRATION on FUNCTIONAL CAPACITY and RESPIRATORY FUNCTIONS IN STROKE INDIVIDUALS: A RANDOMIZED CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Respiratory Function Impaired
Keywords: Stroke
Bobath approach
whole body vibration
functional capacity
respiratory function
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While there is only one study examining the effect of WBV on oxygen consumption and cardiovascular responses in individuals with stroke, no study has been found on the effect of WBV on respiratory capacity and flow volumes and changes in functional capacity due to effort. In this study, it was aimed to investigate whether the WBV treatment protocol determined has an effect on functional capacity and respiratory functions in individuals with stroke.


Eligibility criteria: Inclusion Criteria:

* having first hemiplegic stroke history at least for 3 months, being clinically stable could stand for at least 1 minute, could walk independently with or without a walking aids.

Exclusion Criteria:

* having any neurological, psychiatric, orthopedic and unstable cardiovascular and pulmonary conditions other than stroke.

Primary outcomes:
measure: Six-minute walking test
timeFrame: 12 months
measure: microQuark® brand PC-based USB spirometer
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Mehmet Duray
Study officials:
affiliation: Suleyman Demirel University
name: Mehmet Duray
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882388: The Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel in Normal Volunteers
Official title: Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: celecoxib
platelet
thrombosis
Volunteers
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

* The prevalence of arthritis which needs celecoxib prescription is high in patients with coronary artery disease.
* The main concern is that celecoxib would increase thrombogenicity by inhibiting the synthesis of prostacyclin in endothelial cells.
* It is not known whether the administration of celecoxib would deteriorate antiplatelet effects of aspirin and clopidogrel which are used after stenting.

Methods:

* Healthy volunteers (n=40)
* Randomization into five subgroups
* aspirin, celecoxib, aspirin+celecoxib, aspirin+clopidogrel, aspirin+clopidogrel+celecoxib
* Medication schedule : medication of each drug for 6 days, blood samples at day 0 and day 7
* Celecoxib 200mg twice a day, and/or aspirin 100mg daily, and/or clopidogrel 75 mg daily
* Platelet function test : light transmittance aggregometry and arachidonic acid metabolite assay among subgroups.

Study hypothesis : The addition of celecoxib does not deteriorate antiplatelet function of aspirin and clopidogrel.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers including both men and women 20\~30 years
* no abnormality in physical examination, 12-lead ECG, and routine laboratory test

Exclusion Criteria:

* Subjects with cardiovascular disease, hemostatic disorder, hypersensitivity to NSAIDs and clopidogrel
* Women with a positive pregnancy test
* smoker
* chronic drinkers
* overweight exceeding 20% of standard body weight

Primary outcomes:
measure: Light transmittance aggregometry : % of inhibition (ADP, collagen)
timeFrame: 7 days
Secondary outcomes:
measure: Urine arachidonic metabolite assay
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205788: Feasibility of Biodynamic Imaging for Predicting Therapeutic Effect in Metastatic Adenocarcinoma of the Pancreas
Official title: Feasibility of Biodynamic Imaging for Predicting Effect of Gemcitabine and Nab-paclitaxel on Metastatic Adenocarcinoma of the Pancreas
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 0
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: primary care clinic and Cancer Clinic patients

Brief summary: The purpose of this study is to determine if you can use an assay on tumor samples to see different patterns in response to the same chemotherapy treatment.

Detailed description: To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and willingness to sign an informed consent and authorization for release of health information for research
2. ≥ 18 years old at time of consent
3. Patients with a diagnosis of metastatic pancreatic cancer (mPC) who have not received prior combination chemotherapy. Exception: prior adjuvant chemoradiation with fluorouracil or gemcitabine is allowed.
4. Patients considered for routine care treatment with gemcitabine and nab-paclitaxel (allowed to receive other experimental therapy with gem/nab backbone if participating in another clinical trial)
5. Measurable disease by RECIST v1.1 criteria
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
7. Willingness to undergo transcutaneous core needle biopsy of metastatic tumor for research purposes
8. Women are eligible to participate if they are of non-childbearing potential or have documentation of a negative pregnancy test (serum or urine β-hCG) within 1 week of the start of protocol treatment.
9. Women and men of childbearing potential must agree to use adequate, highly effective contraceptive measures during protocol treatment
10. Laboratory values: Platelets ≥ 100 K/mm3 international normalized ratio (INR) \< 1.2, Partial thromboplastin time (PTT) in normal range, Cr \< 2.0, Total bilirubin \< 2 times upper limit normal (ULN), transaminases \< 5 times ULN

Exclusion Criteria:

1. History of abnormal bleeding with minor procedures or documented platelet aggregation disorder such as VonWillebrand disease
2. Women who are pregnant or breastfeeding

Primary outcomes:
measure: BDI as a chemosensitivity assay on fresh tumor samples
timeFrame: up to 336 days
Secondary outcomes:
measure: BDI patterns and results with Response Evaluation Criteria
timeFrame: up to 336 days
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University
name: Bert O'Neil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06693388: WBV and Serial Casting for Children with Cerebral Palsy
Official title: Whole-body Vibration for Children with Cerebral Palsy Undergoing Serial Casting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Cerebral Palsy
Keywords: Serial Casting
Whole body Vibration
Cerebral Palsy
Pediatrics
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active exercises and serial casting has not been previously explored. Serial casting is the repeated application of a fiberglass cast (such as that applied to manage stable fractures) on a scheduled (usually weekly basis) to gradually increase the range of motion at a specific joint. It is theorized that combining previously established standard of care practices may result in more rapid clinical change, and hence reduce the need for prolonged intervention; ultimately reducing healthcare costs.


Eligibility criteria: Inclusion Criteria:

* Ages 3-17 and 32 weeks exclusive years;
* Diagnosis of cerebral palsy;
* GMFCS levels I-III;
* Stands with upper extremity support or less support;
* Active referral from a prescribing provider for serial casting with ankle DF of \<10 degrees;
* Willing to pursue care at \[primary site\] outpatient physical therapy clinic for the duration of the study;
* Subjects/families must be able to communicate in the English language without the need for interpreter.

Exclusion Criteria:

* History of selective dorsal rhizotomy;
* previous Achilles tendon lengthening or other orthopedic interventions to the lower extremities in 1 year prior to enrollment;
* No Botox or changes in oral medication to reduce spasticity within 6 months prior to enrollment;
* skin, circulation, vascular conditions;
* Previous history of cancer;
* Reduced ankle/foot sensation;
* Allergies to casting materials.

Primary outcomes:
measure: Ankle Dorsiflexion Range of Motion (Goniometer)
timeFrame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Secondary outcomes:
measure: Pain (Visual Analogue Scale/Wong-Baker Faces)
timeFrame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
measure: Length of Casting Episode (Weeks)
timeFrame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Other outcomes:
measure: Adverse effects
timeFrame: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03521388: Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Official title: Efficacy of a Stepped Internet-based Program for Prevention and Early Intervention of Depression in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: depression
adolescence
prevention
early intervention
internet-based
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
name: Millennium Institute for Research in Depression and Personality (MIDAP)
First posted: 2018-05-11
Enrollment: 947
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents.

Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile.

Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.


Eligibility criteria: Inclusion Criteria:

* Attending from ninth grade to eleventh grade in the eight participating schools.
* Informed consent and informed assent.
* Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14.

Exclusion Criteria:

* High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more.
* Current treatment with antidepressant drugs.
* Current treatment with psychotherapy.

Primary outcomes:
measure: Depressive Symptoms
timeFrame: 6 months after baseline assessment
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: 12 months after baseline assessment
measure: Anxiety Symptoms
timeFrame: 6 and 12 months after baseline assessment
measure: Health-Related Quality of Life Index
timeFrame: 6 and 12 months after baseline assessment
measure: Social Problem Solving Skills
timeFrame: 6 and 12 months after baseline assessment
measure: Dysfunctional Thoughts
timeFrame: 6 and 12 months after baseline assessment
measure: Emotion Regulation
timeFrame: 6 and 12 months after baseline assessment
measure: Depression Stigma
timeFrame: 6 and 12 months after baseline assessment
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: CEMERA, Faculty of Medicine, Universidad de Chile
state: Region Metropolitana
Study officials:
affiliation: University of Chile
name: Vania Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01685788: Study of Sensory Deficits in the Upper Limb After Stroke
Official title: Prospective Longitudinal Study: Sensory Deficits in the Upper Limb After Stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2012-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stroke patients

Brief summary: The overall aim of the project is to gain insight in sensory deficits and recovery patterns in the upper limb post stroke and its association with brain lesion localisation. Furthermore, the investigators will identify associations of deficits in sensory modalities with upper limb impairments, activities and participation at different time points after stroke. Identification of the sensory deficits, along with further insights in their relation with objective neurophysiological and neuroanatomical measures will contribute to the amelioration of goal-setting for the rehabilitation of upper extremity function after stroke. These functions are indispensable during several daily activities as well in different sports and leisure activities. This project is an important step towards a better delineating of treatment interventions for the upper limb and to a better guiding of individual needs for post-stroke treatment in the future.


Eligibility criteria: Inclusion Criteria:

* first-ever stroke as defined by WHO
* ≤ 5 days post stroke
* motor impairment and/or a sensory impairment
* ≥ 18 years old
* sufficient cooperation to execute evaluations

Exclusion Criteria:

* other neurological impairments such as previous stroke, head injury or multiple sclerosis (these might affect sensory ability independently of the stroke)
* stroke-like symptoms caused by subdural hematoma, tumour, encephalitis or trauma
* no informed consent
* pre-stroke Barthel Index \< 95 out of 100 points (to be able to distinguish between pre-existing disabilities and disabilities resulting from the stroke)

Primary outcomes:
measure: Change in sensory function in upper limb from baseline up to 6 months post stroke
timeFrame: 6 months post stroke
Secondary outcomes:
measure: Change in motor function in upper limb from baseline up to 6 months post stroke
timeFrame: 6 months post stroke
Other outcomes:
measure: activity measure
timeFrame: 6 months post stroke
measure: Activity measure
timeFrame: 6 months after stroke
measure: Participation measure
timeFrame: 6 months after stroke
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Catholic University Leuven
name: Geert Verheyden, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University Leuven
name: Sarah Meyer, PhD student
role: PRINCIPAL_INVESTIGATOR
References: