louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01263743: Relaxation Response Training to Treat Hypertension
Official title: Relaxation Response Training to Treat Hypertension: Effects on Blood Pressure, Biomarkers, and Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Stage 1 hypertension
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2010-12-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Interventions such as Relaxation Response appear to have widespread effects on physiology. Endothelial function, changes in genomic expression, several biomarkers have been associated with chronic stress and cardiovascular dysfunction, and there is some suggestion that elicitation of the Relaxation Response may lead to improvement in-or normalization of-these factors. By studying the impact of the Relaxation Response on endothelial function, genomic expression and biomarkers among subjects with hypertension, it may be possible to better understand the biologic underpinnings of Relaxation Response-type interventions. Furthermore, with a greater understanding of the physiologic mechanisms by which the Relaxation Response works, it may be possible to better target other symptoms and conditions that can be effectively treated by such an intervention.


Eligibility criteria: General Inclusion Criteria:

* Healthy men and women
* Hypertension (stage 1)
* 18-70 years old

General Exclusion Criteria

* No asthma or nasal allergies
* Non-smokers
* If on anti-hypertensive medication willing to discontinue
* Cannot currently practice Tai Chi, meditation, or yoga regularly
* Current use of the following medications: phosphodiesterase type 5 inhibitors, long-acting nitrates, systemic corticosteroids, anti-inflammatories, immunosuppressive or cytotoxic therapies (currently or within the last 12 months), anabolic steroids, and antidepressants.

Primary outcomes:
measure: Endothelial Function
timeFrame: Eight weeks of Relaxation Response Training
Secondary outcomes:
measure: Blood Pressure
timeFrame: Eight Weeks of Relaxation Response Training
measure: Genomic Expression
timeFrame: Eight Weeks of Relaxation Response Training
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeffrey Huffman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Randall Zusman, MD
role: STUDY_DIRECTOR
affiliation: Brigham and Women's Hospital
name: Mark A Creager, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: John W Denninger, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Herbert Benson, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Gregory Fricchione, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04590443: Ultrasound-guided Neuromodulation Percutaneous
Official title: Ultrasound-guided Percutaneous Neuromodulation on Hip Muscle Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 60
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: TREATMENT

Brief summary: Chronic low back pain (LBP) is one of the most familiar musculoskeletal pains and alone has been the main origin of years lived with disability for the past three decades. LBP is identified as a nonspecific, painful or mechanical situation in the lower back, buttocks, or hips. Although an underlying origin in chronic LBP has been proposed to be due to a multitude of factors, a muscle hip disbalance has been recognized5. A limited hip internal rotation range of motion (IR-ROM) and hip abductor weakness were found in patients with LBP symptoms7

In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. However, authors hypothesize that neuromodulation (especially the US-guided PNM technique) may be used to obtain more therapeutic effects, including pain relief.

The main aim of this study was to investigate the effect of hip muscle strengthening by a simple single-shot procedure with the US-guided PNM technique in people with LBP. A second purpose was to discover if the stimulation point in the sciatic nerve territory may influence the change of strength in these patients Sixty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Lower Back Pain
* Having no other therapy

Exclusion Criteria:

* Other pathology (discal hernia, injured limbs, neurological pathology)
* Belenophobia

Primary outcomes:
measure: Level of pain
timeFrame: From baseline measurement up to 1 week
measure: Hip internal rotation range of motion
timeFrame: From baseline measurement up to 1 week
measure: Muscle strength
timeFrame: From baseline measurement up to 1 week
measure: Owestry questionnaire
timeFrame: From baseline measurement up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Blanca de la Cruz Torres
Study officials:
References:
Clinical trial NCT04308538: Bil. LR Rec. Using Standard Tables VS Reduced Numbers in Intermittent Exo. in Children Under 6
Official title: Bilateral Lateral Rectus Recession Using Standard Tables Versus Bilateral Lateral Rectus Recession Using Modified Reduced Numbers in Intermittent Exotropia in Children Less Than 6 Years Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alternating Exotropia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter


Eligibility criteria: Inclusion Criteria:

* Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9)
* Basic, pseudo- divergence excess and divergence excess types are included.
* If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector).

Exclusion Criteria:

* Intermittent exotropia of the convergence insufficiency type.
* Intermittent exotropia with angle of deviation greater than 50 prism diopters.
* Patients with previous squint surgery.
* Patients with secondary deviation due to a sensory lesion or neurological condition.

Primary outcomes:
measure: Motor success rate
timeFrame: 6 months
Secondary outcomes:
measure: Pattern strabismus
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Cairo university
Study officials:
affiliation: Cairo University
name: Ayman Elshiaty, MD
role: STUDY_CHAIR
References:
citation: Haggerty H, Richardson S, Hrisos S, Strong NP, Clarke MP. The Newcastle Control Score: a new method of grading the severity of intermittent distance exotropia. Br J Ophthalmol. 2004 Feb;88(2):233-5. doi: 10.1136/bjo.2003.027615.
citation: Pratt-Johnson JA, Barlow JM, Tillson G. Early surgery in intermittent exotropia. Am J Ophthalmol. 1977 Nov;84(5):689-94. doi: 10.1016/0002-9394(77)90385-3. No abstract available.
citation: Abroms AD, Mohney BG, Rush DP, Parks MM, Tong PY. Timely surgery in intermittent and constant exotropia for superior sensory outcome. Am J Ophthalmol. 2001 Jan;131(1):111-6. doi: 10.1016/s0002-9394(00)00623-1.
citation: Buck D, Powell CJ, Sloper JJ, Taylor R, Tiffin P, Clarke MP; Improving Outcomes in Intermittent Exotropia (IOXT) Study group. Surgical intervention in childhood intermittent exotropia: current practice and clinical outcomes from an observational cohort study. Br J Ophthalmol. 2012 Oct;96(10):1291-5. doi: 10.1136/bjophthalmol-2012-301981. Epub 2012 Aug 11.
Clinical trial NCT00923338: Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
Official title: Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vesico-vaginal Fistula
Keywords: fistula
vesico-vaginal fistula
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2009-06-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.


Eligibility criteria: Inclusion Criteria:

* Patient has signed and dated the informed consent.
* Patient is 18 years old; or is an emancipated minor as defined by Ugandan law or is under 18 but has a parent/guardian who provides informed consent.
* Patient agrees to follow-up schedule.
* Patient presents with a leaking vesico-vaginal fistula, confirmed by exam, with no signs of acute inflammation, no signs of active urinary tract infection that cannot be controlled with a standard pre-operative course of antibiotics, no signs of vaginal infection, or no signs of abscess.
* Patient presents with a fistula of a size and in a location that may be reasonably treated with the VVP device.

Exclusion Criteria:

* Patient is not medically fit enough for surgery under general or spinal anesthesia.
* Patient is a "mature minor" as defined by Ugandan law.
* Patient is pregnant, breastfeeding or planning further pregnancy during the study period.
* Patient has physical allergies or cultural objections to the receipt of porcine products.
* Patient has an active sexually transmitted disease, is HIV-positive, or any other active systemic infection that may interfere with healing.
* Patient has spina bifida or other neural tube defect.
* Patient has interstitial cystitis or other chronic pelvic pain syndrome.
* Patient has signs of acute or chronic pelvic inflammation, active urinary tract infection not responsive to antibiotic treatment, vaginal infection, or abscess of the fistula tract.
* Patient presents with clinically diagnosed sepsis (for whatever reason).
* Patient has concomitant ureterovaginal fistula.

Primary outcomes:
measure: Fistula
timeFrame: 4 months
measure: Adverse Events
timeFrame: 4 months
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University Teaching Hospital
Study officials:
affiliation: Mbarara University Teaching Hospital
name: Musa Kayondo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03691038: Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin
Official title: Comparison of Conventional Flexible Dose Regimen of Pregabalin and New Flexible Dose Regimen of Pregabalin Using Low Dose: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Neuropathic
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
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 propose a new flexible dose regimen starting from 75mg using the low dose pregabalin 25 mg and 50 mg comparing the side effect and compliance with the conventional flexible dose regimen staring from 150mg using the pregabalin 75mg.

Detailed description: Pregabalin has been shown to be effective as a first-line medication for neuropathic pain but it appears to have several side effects such as dizziness, drowsiness, and edema, which lowers compliance with medications. A way to reduce side effects is the flexible dose regimen, which reaches the target dose to treat the drug. The proposed flexible dose regimen is a regimen that begins with twice the prevalence of 75 mg. However, dizziness is the most common side effect up to 20% in conventional flexible dose regimen. Therefore, the aim of this study was to propose a new flexible regimen starting at a dose less than the existing dose and to compare compliance with pregabaline according to both methods

Eligibility criteria: Inclusion Criteria:

* Pain score NRS ≥3 Patients complaining of neuropathic pain (except neuropathic pain due to chemotherapy)
* Adult patients aged 19 to 85 years
* Patients who pre-agreed to the study

Exclusion Criteria:

* Patients complaining of severe pain (NRS ≥ 8)
* Creatinine clearance of \<30 mL / min, the liver was more than 3 times normal
* Patients complaining of dizziness, patients with definite orthostatic hypotension
* Pregnant or lactating patients
* Patients who previously experienced side effects after administration pregabalin.

Primary outcomes:
measure: discontinuation of medication
timeFrame: After 7 weeks of prescription
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Sung Hyun Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05413538: Effects of a Mindfulness-Based Intervention Delivered Via Instant Messaging on Parents' Wellbeing: A Randomized Controlled Trial and Investigation of Moderators
Official title: Effects of a Mindfulness-Based Intervention Delivered Via Instant Messaging on Parents' Wellbeing: A Randomized Controlled Trial and Investigation of Moderators
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parents
Stress
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research investigates the effects of mindfulness practice on mental wellbeing with the instruction recordings delivered via existing instant messaging applications, Whatsapp. The two-week mindfulness program targets parents with children in Secondary School or below. This research also explores how parenting and attachment styles moderate the intervention effects.


Eligibility criteria: Inclusion Criteria:

Parents with at least one child who is in Secondary School or below

Primary outcomes:
measure: Parental Stress Scale
timeFrame: Change from Baseline Parental Stress Scale at immediately after the intervention and two weeks after intervention
measure: Interpersonal Mindfulness in Parenting Scale
timeFrame: Change from Baseline Interpersonal Mindfulness in Parenting scale at immediately after the intervention and two weeks after intervention
measure: Non-attachment to Self Scale
timeFrame: Change from Baseline Non-attachment to Self Scale at immediately after the intervention and two weeks after intervention
measure: Nonattachment Scale - Short Form
timeFrame: Change from Baseline Nonattachment Scale - Short Form at immediately after the intervention and two weeks after intervention
measure: Peace of mind
timeFrame: Change from Baseline Peace of mind Scale - Short Form at immediately after the intervention and two weeks after intervention
Secondary outcomes:
measure: The Experiences in Close Relationship Scale-Short Form
timeFrame: Change from Baseline The Experiences in Close Relationship Scale - Short Form at immediately after the intervention and two weeks after intervention
measure: Training Scale
timeFrame: Change from Baseline Training Scale at immediately after the intervention and two weeks after intervention
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT06760338: Factors Associated With Quality of Life in Knee Osteoarthritis
Official title: Factors Associated With Quality of Life in Patients With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include people aged between 40-65 years, who volunteered to participate in the study and diagnosed with knee osteoarthritis.

Brief summary: The aim of this study was to investigate the relationship between quality of life and factors that may affect quality of life (pain, stiffness, functional status and depression) in knee osteoarthritis.

Detailed description: Participants aged between 40-65 years, willing to participate in the study and diagnosed with knee osteoarthritis will be included in the study. Necessary demographic information will be obtained with the prepared data form. Numerical Rating Scale (NRS), Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC Osteoarthritis Index), Knee Injury and Osteoarthritis Outcome Score (KOOS), Lower Extremity Functional Scale (LEFS), Beck Depression Scale, Short Form - 36 (Quality of Life Questionnaire) will be used for evaluation. The data obtained in the study will be entered into SPSS 17 package programme (Greasley, 2007). Minimum-maximum values, arithmetic mean and standard deviation will be used to evaluate numerical data, and frequency distributions and percentages will be used to summarise categorical data. The data of the study will be analysed using Analysis of Moment Structures (AMOS) statistical package programmes. In all analyses, p\<0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being diagnosed with knee osteoarthritis
* In studies between the ages of 40 and 65

Exclusion Criteria:

* Other orthopaedic surgery in the lower extremity
* Cognitive impairment at a level that prevents understanding and answering the questionnaire
* Presence of neurological disease

Primary outcomes:
measure: Numerical Rating Scale - NRS
timeFrame: 1 minute
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 3 minute
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 5 minute
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 2 minute
measure: Beck Depression Scale
timeFrame: 5 minute
measure: Short Form - 36 Quality of Life Questionnaire (SF-36)
timeFrame: 7 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: Kutahya Health Science University
name: Emrah Afsar, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02388438: Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity
Official title: Efficiency and Safety of Demineralized Bone Matrix in the Proximal Opening Wedge Osteotomy for Hallux Valgus Deformity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hallux Valgus
Keywords: demineralized bone matrix
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the demineralized bone matrix in "Hallux valgus".

Detailed description: Demineralized bone matrix use for filling in the space removed bone in open wedge osteotomy and correction. The purpose this study is to test therapeutic benefits of demineralized bone matrix.

Investigator will recruit thirty patients. Total evaluation period will be 12 months. In this period, investigator will examine correction rate, fusion rate, functional test, adverse event.

Eligibility criteria: Inclusion Criteria:

* (1) The patient ranging in age from 20 to 75 years
* (2) Has to be operated over 5mm osteotomy for correcting hallux valgus.
* (3) The patients who were able to comply with the research protocol.

Exclusion Criteria:

* (1) Bursitis in metatarsal bones has affected surgery.
* (2) Has rheumatism
* (3) The patient who has clinical sign of infection on the operated site at pre-screening
* (4) Patient who has failure of peripheral blood circulation caused by chronic disease and neurological symptoms
* (5) In the opinion of investigator, the patient is not suitable to participate in this study

Primary outcomes:
measure: days to union from applied demineralized bone matrix
timeFrame: up to 12months
Secondary outcomes:
measure: Complete fusion rate after applied medical device.
timeFrame: up to 12months
measure: Complete correction rate after applied medical device.
timeFrame: up to 12months
measure: Change from baseline AOFAS(American Orthopaedic Foot and Ankle Society) at 12 months.
timeFrame: change form baseline at 12months
Other outcomes:
measure: Adverse events
timeFrame: up to 12months
Locations:
Study officials:
References: