louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00751829: Isolated Systolic Hypertension in the Elderly and Very Elderly
Official title: Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Isolated Systolic Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 417
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.


Eligibility criteria: Inclusion Criteria:

* Age 65 or older
* Mean sitting BP \>160 mmHg and mean sitting dBP\<90 mmHg

Exclusion Criteria:

* Secondary hypertension
* Malignant hypertension
* Severe Heart Failure (NYHA III-IV)
* Recent history of myocardial infarction
* Hypersensitivity to study medications
* History of drug or alcohol abuse
* History or evidence of renal disease

Primary outcomes:
measure: Change in mean sitting systolic blood pressure as assessed by conventional BP measurements
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in mean sitting systolic blood pressure assessed by conventional BP measurements
timeFrame: After 1, 2, 4, 8, 12, 16, 20, and 24 weeks
measure: Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP
timeFrame: after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment
Other outcomes:
Locations:
city: Munich
country: Germany
Study officials:
affiliation: IMFORM GmbH
name: Peter U Witte, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00042029: Treatment of Patients With Major Depressive Disorder With MK0869 (0869-073)
Official title: A Double-Blind, Multicenter, Placebo-Controlled Study of MK0869 in the Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-07-23
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression.

Detailed description: The duration of treatment is 8 weeks.

Eligibility criteria: Patients with Major Depressive Disorder

Primary outcomes:
measure: HAMD-17 total score; Tolerability
Secondary outcomes:
measure: CGI-I Scale score; Sheehan Disability Scale
Other outcomes:
Locations:
Study officials:
References:
citation: Keller M, Montgomery S, Ball W, Morrison M, Snavely D, Liu G, Hargreaves R, Hietala J, Lines C, Beebe K, Reines S. Lack of efficacy of the substance p (neurokinin1 receptor) antagonist aprepitant in the treatment of major depressive disorder. Biol Psychiatry. 2006 Feb 1;59(3):216-23. doi: 10.1016/j.biopsych.2005.07.013. Epub 2005 Oct 24.
Clinical trial NCT06911229: Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
Official title: Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Freezing of gait
deep brain stimulation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. Split-belt walking will be performed under DBS ON and DBS OFF conditions, while off-medication.

Detailed description: We will test the hypotheses that DBS can facilitate split-belt walking adaptation with DBS ON compared with DBS OFF.

Eligibility criteria: Inclusion Criteria:

* consensus diagnosis of idiopathic PD by fellowship trained movement disorders neurologists at the Normal Fixel Institute of Neurological Diseases;
* chronically stable DBS, defined as having had DBS for at least 6 months in duration with optimized DBS settings;
* Age between 18 - 80 years old per the FDA data sheet for PD DBS;
* no dementia according to the clinical diagnostic criteria for PD dementia;
* ambulatory without the use of walking aids, or another person's assistance.

Exclusion Criteria:

* other previous neurological surgery;
* suspicion of other neurologic diagnoses such as atypical parkinsonism, or Alzheimer's disease.

Primary outcomes:
measure: Step length rate of adaptation
timeFrame: 1 hour
measure: Step length magnitude of adaptation
timeFrame: 1 hour
measure: Step length after-effects
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04727229: Stellate Ganglion Block for Major Depressive Disorder.
Official title: Stellate Ganglion Block for Major Depressive Disorder: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Treatment Resistant Depression
Major Depressive Disorder
Keywords: Feasibility trial
Stellate Ganglion Block
Bupivacaine
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a feasibility study, to investigate a new treatment option for major depressive disorders by performing a Stellate Ganglion Block (SGB). A SGB is an injection of local anesthetic into the sympathetic nervous system (peripheral nervous system) located in the lower part of the neck, to relieve pain in the head, neck, upper arm, and upper chest.


Eligibility criteria: Inclusion Criteria:

1. 18 - 65 years of age
2. Major depressive disorder without psychotic symptoms according to DSM-5 criteria
3. Hamilton Depression Rating Scale (HAMD)\>17
4. Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI)
5. Failure of at least two trials of antidepressant therapy during the current episode
6. Capacity to provide informed consent

Exclusion Criteria:

1. Depression secondary to stroke, cancer or other severe medical illness
2. Major Depressive Episode in people with Bipolar Disorder.
3. Dementia
4. Post-Traumatic Stress Disorder (PTSD)
5. Acute suicidality defined as score ≥3 on HAMD item 3
6. Previous electroconvulsive therapy
7. Known history of intolerance of hypersensitivity to local anesthetic
8. Current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined in DSM-5 criteria
9. Unwilling to maintain current antidepressant regimen.
10. A clinical finding/condition that is unstable or that, in the opinion of the investigator(s) would negatively be affected by an SGB (e.g. movement disorder where patient is unable to lie still for injection or anatomical variants making an SGB impractical).

Primary outcomes:
measure: Feasibility, Recruitment, Acceptability, Safety,
timeFrame: 1 year
Secondary outcomes:
measure: Change in the symptoms of depression
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Karim Ladha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sussman D, Tassone VK, Gholamali Nezhad F, Wu M, Adamsahib F, Mattina GF, Pazmino-Canizares J, Demchenko I, Jung H, Lou W, Ladha KS, Bhat V. Local Injection for Treating Mood Disorders (LIFT-MOOD): A Pilot Feasibility RCT of Stellate Ganglion Block for Treatment-Resistant Depression. Chronic Stress (Thousand Oaks). 2023 Mar 3;7:24705470231160315. doi: 10.1177/24705470231160315. eCollection 2023 Jan-Dec.
Clinical trial NCT00636129: Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
Official title: Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Keywords: relaxation
relaxation response
meditation
nitric oxide
stress management
stress
Relaxation Techniques
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects ages 18-49.

Brief summary: We are looking at the effects of Stress Management and Relaxation Response training on stress hormones (like adrenalin and cortisol), immune function and physiology (heart rate, breathing rate, muscle tension).

Detailed description: The primary aim of this study is to determine whether differing durations of relaxation response (RR) training will be associated with different degrees of change in physiological, psychological, hormonal, molecular and immunological markers. Prior studies have reported reduction on many of these parameters after 8 weeks of RR training. However, we now seek to understand the degree to which incremental decreases in these parameters are exhibited at 0, 4, and 8 weeks of RR practice in 30 healthy adults. Furthermore, we will explore correlations between levels of exhaled nitric oxide or plasma nitrites/nitrates and oxygen consumption during RR elicitation. We will also examine any associations between changes in oxygen consumption and psychological factors, physiological parameters, and biochemical outcomes. Lastly, we will bank plasma and peripheral blood cells from these samples for future assessments of immune markers, cell typing and gene expression.

Eligibility criteria: Inclusion Criteria:

* Age 18-49
* Healthy subjects

Exclusion Criteria:

* Taking medication
* Asthma or allergies
* Prior regular relaxation practice
* Body Mass Index \>39
* Beck Depression Inventory (BDI) score indicates possible clinical depression
* Current mental health treatment
* Diagnosis of severe mental illness
* Using hormonal birth control
* Females: pregnant or trying to conceive
* Exhaled Nitric Oxide (NO) levels \> 60PPB
* Hematocrit \< 32%
* Blood glucose \< 50 or \> 200
* Creatinine \> 1.3

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Benson-Henry Institute for Mind Body Medicine
state: Massachusetts
Study officials:
affiliation: Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hosptial
name: Herbert Benson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706029: Pain Evaluation in Rheumatoid Arthritis
Official title: Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 300
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 are selected from those coming to the Department of Rheumatology of each partcipating center.

Brief summary: Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the priority domain of improvement for the patients instead a good control of the inflammatory disease by treatments, even biotherapeutics .

Some studies show that less than 50 % of the patients is satisfied by the care of the pain, whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a complex and multifactorial subjective phenomenon requiring a multidimensional evaluation, while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain in a single dimension that is the pain intensity.

So, the investigators do not arrange explanation for this observed dichotomy between the improvement of the clinical and biological inflammatory criteria of the RA and on the other hand the persistence of pain.

On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the physiopathology of RA and probably in the pain processing according to recent data of the literature.

The aim of this study is:

* to assess the multidimensional origin of the pain in RA patients by means of questionnaires
* to look for a possible correlation between the serum level of cytokines and pain.


Eligibility criteria: Inclusion Criteria:

* Adults with RA treated with DMARDs and/or biotherapy,
* Capable of providing written consent

Exclusion Criteria:

* Patients affected by a painful disease other one than RA,
* Fibromyalgia,
* A malignancy disease,
* An hemopathy,
* Psychiatric disorders or dementia and
* Acute infectious diseases and
* Receive or had received anti-IL6 therapy

Primary outcomes:
measure: Evaluation of the pain
timeFrame: At day 1
Secondary outcomes:
measure: Patients pain care
timeFrame: At day 1
measure: Correlation
timeFrame: At day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux- Pellegrin
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Lille
country: France
facility: CHU Hôpital R. Salengro
city: Limoges
country: France
facility: Service de Rhumatologie
city: Paris
country: France
facility: CHU Hôtel-Dieu
city: Rouen
country: France
facility: CHU Bois-Guillaume
city: Strasbourg
country: France
facility: CHU Hautepierre
Study officials:
affiliation: CHU Limoges
name: Pascale Vergne-Salle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304329: Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin
Official title: Relative Bioavailability of BI 10773 and Simvastatin After Single and Combined Administration - an Open-label, Randomised, Crossover Trial in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.


Eligibility criteria: Inclusion criteria:

- healthy male and female subjects

Exclusion criteria:

- Any relevant deviation from healthy conditions

Primary outcomes:
measure: Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
measure: Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
measure: Empa: Maximum Measured Concentration (Cmax)
timeFrame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
measure: Simvastatin: Maximum Measured Concentration (Cmax)
timeFrame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Secondary outcomes:
measure: Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
measure: Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1245.63.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06330129: Validity and Reliability of Trunk Strength Device
Official title: Validity and Reliability of Trunk Muscle Strength Assessements With Isometric Dynamometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trunk Muscle Strength
Keywords: Trunk muscle strength
Isometric device
Pegasus
Validity
Reliability
Muscle Activation
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Balgrist Campus AG
First posted: 2024-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to evaluate the accuracy and consistency of assessing trunk muscle strength using an isometric device (Pegasus, Leipzig, Germany). Thirty healthy volunteers will undergo maximal isometric strength testing with the device, repeated one week later to assess repeatability. Surface electrodes will measure muscle activation, while MRI scans will assess structural condition.

Detailed description: The aim of the study is to assess the validity and repeatability of trunk muscle strength evaluation using an isometric device (Pegasus, Leipzig, Germany) and to investigate it. Thirty healthy volunteer participants will undergo testing of maximal isometric (non-moving) strength using this device. The same strength measurement procedure will be repeated one week later for all participants to determine if the measurements are repeatable, i.e., if the device is capable of providing similar strength data in two closely timed measurements. To assess whether the device actually provides reliable strength data for the trunk muscles, surface electrodes will be additionally placed on the involved muscles to understand the extent of neural activation of these muscles during the test. Additionally, an MRI examination will be conducted for all study participants to assess the structural condition of the trunk muscles.

Eligibility criteria: Inclusion Criteria:

* both male and female subjects
* age between 18 and 59 years
* BMI \< 30 kg/m2
* cognitively intact (self-reported)
* autonomous walking

Exclusion Criteria:

* age under 18 years or over 60 years
* any prior spinal surgery or other musculoskeletal surgery having an impact on movement
* acute or chronic back pain in the last 6 months(self-reported)
* pregnancy (self-reported)
* inability to perform the planned set of activities included in the study (e.g. maximal voluntary contraction torque test)
* inability to give consent

Primary outcomes:
measure: maximal isometric trunk muscle strength
timeFrame: 1 hour
Secondary outcomes:
measure: MRI muscle morphology
timeFrame: 0.5-1hour
measure: Electromyography (EMG) activity
timeFrame: 1hour
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References:
Clinical trial NCT04230629: Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
Official title: Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age Related Cataracts
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination.
Primary purpose: DIAGNOSTIC

Brief summary: On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.

A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
* Age 40 and older
* Astigmatism of at least 0.75Diopters in one eye
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Diabetes mellitus
* Pseudoexfoliation syndrome
* Systemical anticoagulation
* Antiphlogistic therapy
* Antiglaucomatosa
* Uncontrolled systemic or ocular disease
* Preceding ocular surgery or trauma
* Intraoperative complications
* Pregnancy/Nursing
* Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days

Primary outcomes:
measure: Number of FBGC (foreign body giant cells) (slitlamp examination)
timeFrame: 5 months
Secondary outcomes:
measure: Incidence of Monocytes (slitlamp examination)
timeFrame: 5 months
measure: PCO Score (slitlamp examination)
timeFrame: 5 months
measure: Grade of Anterior Fibrosis (slitlamp examination)
timeFrame: 5 months
measure: Anterior chamber reaction (slitlamp examination)
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
References: