louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01963507: Effects of a Resistance Training Period on Blood Pressure of Hypertensive Elderlies: Influence of the Polymorphism of the Angiotensin Converting Enzyme
Official title: Effects of a Resistance Training Period on Blood Pressure of Hypertensive Elderlies: Influence of the Polymorphism of the Angiotensin Converting Enzyme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-10-16
Enrollment: 136
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to evaluate the chronic effects of resistance training on blood pressure and biochemical exams in hypertensive elderlies and the influence of the polymorphism of the angiotensin converting enzyme in these response.

Detailed description: To investigate the chronic effects of resistance training on blood pressure and biochemical exams in elderly, 135 hypertensive elderlies were divided into 2 groups: trained and control. The trained group was submitted to a resistance training period. Before the 16 weeks ACE gene was genotyped (PCR). Before and after 16 weeks, blood pressure (ambulatory), HDL-cholesterol, Total cholesterol, Glycemia, Triacylglycerol (colorimetric assay) and plasminogen activator inhibition (PAI-1), intercellular adhesion molecule (ICAM-1), vascular endothelial cell adhesion molecule (VCAM-1), Adiponectin, tumor necrosis factor alpha (TNF-alpha), C Reactive Protein, Angiotensin II, Angiotensin Converting Enzyme, Angiotensin 1-7, (ELISA assay) were measured.

Eligibility criteria: Inclusion Criteria:

* Hypertensives
* Age 60 to 85 years
* Nonactive

Exclusion Criteria:

* Orthopedic problems or other problem that prevented the exercises
* Change in drug treatment during protocol
* Absence in more than 25% of the exercise sessions

Primary outcomes:
measure: Blood Pressure
timeFrame: 16 weeks
Secondary outcomes:
measure: HDL-cholesterol
timeFrame: 16 weeks
measure: Total Cholesterol
timeFrame: 16 weeks
measure: Glycemia
timeFrame: 16 weeks
measure: Triacylglycerol
timeFrame: 16 weeks
measure: PAI-1
timeFrame: 16 weeks
measure: ICAM-1
timeFrame: 16 weeks
measure: VCAM-1
timeFrame: 16 weeks
measure: Adiponectin
timeFrame: 16 weeks
measure: TNF alpha
timeFrame: 16 weeks
measure: C Reactive Protein
timeFrame: 16 weeks
measure: Angiotensin II
timeFrame: 16 weeks
measure: Angiotensin Converting Enzyme
timeFrame: 16 weeks
measure: Angiotensin 1-7
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: UNIMED
state: SP
Study officials:
References:
Clinical trial NCT05747807: Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
Official title: Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disk Herniated Lumbar
Radicular Pain
Intradiscal Radiofrequency
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group pre-posttest design
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to demonstrate the efficacy of percutaneous intradiscal radiofrequency as a treatment for radicular pain from lumbar disc herniation.

The main question it aims to answer is:

• Can percutaneous intradiscal radiofrequency lower the severity of radicular pain from lumbar disc herniation Participants will be treated with percutaneous intradiscal radiofrequency and evaluated for radicular pain severity before and 3 months after the procedure.

There is no comparison group.


Eligibility criteria: Inclusion Criteria:

1. 18-85 year-old patients with radicular pain from lumbar disc herniation for ≥ 3 months
2. Lumbar disc herniation ≤ 2 locations evidenced by MRI, with ≥ 50% remaining disc height, without disc sequestration
3. Previously treated with epidural steroid injection (ESI) and achieved ≥ 50 % pain relief from local anesthetic effect, confirming radicular pain from lumbar disc herniation, but did not respond to ESI (\< 50 % Pain relief or pain relief \< 3 months)

Exclusion Criteria:

* Patient refusal
* Discitis
* Previous lumbar spine surgery
* Progressive neurological deficit and/or cauda equina syndrome
* Coagulopathy
* Allergic to any medication in study protocols
* Unable to rate the pain
* Pain in any area worse than the radicular pain

Primary outcomes:
measure: Change from baseline radicular pain score at 2 weeks
timeFrame: pre-treatment and 2 week post-treatment
measure: Change from baseline radicular pain score at 3 months
timeFrame: pre-treatment and 3 months post-treatment
Secondary outcomes:
measure: Oswestry Disability Index (ODI) at baseline
timeFrame: pre-treatment
measure: Oswestry Disability Index (ODI) at 2 weeks
timeFrame: 2 week post-treatment
measure: Oswestry Disability Index (ODI) at 3 months
timeFrame: 3 month post-treatment
measure: WHOQOL-Brief total score at baseline
timeFrame: pre-treatment
measure: WHOQOL-Brief total score at 2 weeks
timeFrame: 2 week post-treatment
measure: WHOQOL-Brief total score at 3 months
timeFrame: 3 month post-treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
References:
Clinical trial NCT02348307: Single Dose Phase I Study of FYU-981
Official title: Single Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 54
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered. The effect of food on PK/PD of FYU-981 is also investigated.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy adult subjects
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Primary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 48 hours
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 48 hours
measure: Pharmacokinetics (MRT: Mean residence time)
timeFrame: 48 hours
measure: Pharmacokinetics (Ae: Amount of drug excreted in urine)
timeFrame: 48 hours
measure: Pharmacokinetics (fe: Fraction of dose excreted in urine)
timeFrame: 48 hours
measure: Pharmacokinetics (CLr: Renal clearance)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Japan
Study officials:
References:
Clinical trial NCT04640207: The Efficacy of the Alma Hybrid System for a New Approach of Facial Skin Treatment
Official title: Prospective, Single-Center, Open-Label Study to Evaluate the Efficacy of the Alma Hybrid System for New Approach of Facial Skin Treatment With Minimal Downtime
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rejuvenation
Lead sponsor: Alma Lasers
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths.

The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. Follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.


Eligibility criteria: Main Inclusion Criteria:

1. Male or Female, 35 to 60 years of age, at the time of enrollment
2. Fitzpatrick skin type I-IV
3. Mild-moderate photo damages and wrinkles, with Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6

Main Exclusion Criteria:

1. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
2. Heavy smoker (\>1 pack of cigarettes a day)
3. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
4. Previous rejuvenation treatments on the same area, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure, or face-lift with laser or other devices, up to 3 months prior to the enrollment
5. Prior use of collagen, fat injections, or other methods of skin augmentation within the past 12 months.
6. Prior use of Botox in the treatment area within 5 months
7. Infection, dermatitis, rash, or other skin abnormality in the target area
8. History of any disease or condition that could impair wound healing
9. History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing

Primary outcomes:
measure: Investigator assessment
timeFrame: 3 month after last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting, P.C.
state: Pennsylvania
Study officials:
affiliation: Dermatology Associates of Plymouth Meeting, P.C.
name: Thomas Griffin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05649007: Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
Official title: Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthropathy of Hip
Lead sponsor: Gruppo Bioimpianti S.r.l.
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 630
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: please see inclusion/exclusion criteria

Brief summary: Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.

Detailed description: The main object of the clinical investigation is the evaluation of Stem (SAPHIR) survival rate. The post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)

Eligibility criteria: Inclusion Criteria:

* patients\>18 years
* Candidate for primary total hip replacement with femoral stem and acetabular cup
* if ostheoarthritis patients aged 18 to 85 years
* if femoral neck fracture patients aged 18 to 90 years
* patients with social security scheme
* patients understands the condition of the study and is willing to partecipate for the duration of the clinical investigation
* patients who gavee consent to partecipare in the clinical investigation

Exclusion Criteria:

* \<18 years
* if female, pregnant
* patient who has already had primary hip surgery on the same side
* local or disseminated neoplastic disease
* inability to understand the study and agree to partecipate
* patients cancelling partecipation before surgery
* patients under guardianship or curatorship
* patients without a social security scheme
* patients refusing to partecipate

Primary outcomes:
measure: stem survival rate
timeFrame: 1 year, 3 years, 5 and 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hopital Ducuing
Study officials:
affiliation: Hopital Ducuing
name: Gerard Giordano, medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02331407: Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke
Official title: Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Orentreich Family Foundation
name: Mailman School of Public Health
First posted: 2015-01-06
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available. While recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients. This study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.


Eligibility criteria: Inclusion Criteria:

1. Hemiparesis of the upper extremity
2. Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry
3. Age 18 years or older
4. Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain.

Exclusion Criteria:

1. Inability to understand and/or follow instructions
2. Pain in shoulder or arm
3. Other neurological or musculoskeletal target organ disorder
4. Inability to give informed consent personally
5. Previous or current contracture of the upper extremity

Primary outcomes:
measure: Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance
timeFrame: From baseline to within 1 week post-therapy
Secondary outcomes:
measure: Fugl-Meyer (FM) Upper Extremity Motor Assessment
timeFrame: baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
measure: Action Research Arm Test
timeFrame: baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Univeristy, Neurological Institute
state: New York
Study officials:
affiliation: Columbia University
name: John Krakauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00553007: The Relation Between Periodontal Disease and Metabolic Syndrome
Official title: The Relation Between Periodontal Disease and Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Disease
Metabolic Syndrome
Keywords: Periodontal disease
Metabolic Syndrome
Lead sponsor: Aichi Gakuin University
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Periodontal disease is associated with the components of Metabolic syndrome, such as obesity, diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal disease and metabolic syndrome is suggested. the overall goal of this study is to define the relation between periodontal disease and metabolic syndrome, including atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* Patients with periodontal disease

Exclusion Criteria:

* Patients with malignant disease
* Pregnant women

Primary outcomes:
measure: features of periodontal disease and metabolic syndrome
timeFrame: one year
Secondary outcomes:
measure: Pulse wave velocity; max Intima-Media Thickness(IMT); mean IMT; ankle-brachial blood pressure index; toe-brachial blood pressure index
timeFrame: one year
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Gakuin University
state: Aichi
Study officials:
affiliation: Aichi Gakuin University
name: Tatsuaki Matsubara, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01296607: Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers - Protocol 4
Official title: Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Heart Failure
Keywords: Pharmacodynamics
Pharmacokinetics
Urocortin 2
Urocortin 3
Reproducibility
Onset/ Offset
Forearm blood flow
Plethysmography
Heart Failure
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2011-02-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research.

Urocortins are proteins that appear to increase blood flow and heart pumping activity. There has been particular interest in the role of Urocortins 2 \& 3 (subtypes of Urocortins) in heart failure.

In this study, we will examine the pharmacokinetics and pharmacodynamics (in particular the onset-offset of action and reproducibility of vasodilator effects) of Urocortins 2 \& 3 on forearm arterial blood flow healthy volunteers.

Utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers between 18 - 65 years (inclusive)

Exclusion Criteria:

* Lack of informed consent- Age \<18 years \> 65 years
* Current involvement in a clinical trial
* Severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure
* Smoker
* History of anaemia
* Recent infective/inflammatory condition
* Recent blood donation (prior 3 months)
* Positive baseline urine test for drugs of abuse (including cannabinoids, benzodiazepines, opiates, cocaine and amphetamines)

Primary outcomes:
measure: Forearm blood flow
timeFrame: 3.5 hours
Secondary outcomes:
measure: Plasma Urocortin 2 and 3 levels
timeFrame: 3.5 hours
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility, Royal Infirmary of Edinburgh
state: Mid Lothian
Study officials:
affiliation: University of Edinburgh
name: David E Newby, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Venkatasubramanian S, Griffiths ME, McLean SG, Miller MR, Luo R, Lang NN, Newby DE. Vascular effects of urocortins 2 and 3 in healthy volunteers. J Am Heart Assoc. 2013 Jan 31;2(1):e004267. doi: 10.1161/JAHA.112.004267.
Clinical trial NCT06291207: A Study to Evaluate the Efficacy and Safety of AD-224
Official title: A Randomization, Double-blind, Active-controlled, Multicenter, Phase 3 Trial to Evaluate the Efficacy and Safety of AD-224A and AD-224B in Patients with Essential Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypertension,Essential
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 252
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of AD-224

Detailed description: Condition or disease : Essential Hypertension

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Patients with Essential Hypertension
* Other inclusions applied

Exclusion Criteria:

* Patient with Secondary Hypertension
* Other exclusions applied

Primary outcomes:
measure: Change rate of MSSBP
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: InHo Chae, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: