louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04936867: The CArdiac Imaging RegistrY Study
Official title: The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease (CAD)
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults referred to clinical cardiac computertomography imaging

Brief summary: In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio.

Particular aims include:

1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
2. To determine associations between CAD severity and plaque type and:

   1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
   2. blood markers of increased cardiovascular risk
3. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
4. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Detailed description: Particular aims include:

1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
2. To determine associations between CAD severity and plaque type and:

   1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
   2. blood markers of increased cardiovascular risk
3. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
4. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Eligibility criteria: Inclusion Criteria:

1. Adults (=/\>18 years of age)
2. Able to provide informed consent
3. Clinical indication for cardio-CT in line with the latest clinical guidelines

Exclusion Criteria:

1. standard contraindications to CT (in line with local roles and guidelines - please see Appendix)
2. known allergy to iodinated contrast agent
3. suspected acute kidney injury
4. unstable hemodynamic status or arrhythmias
5. suspected acute coronary syndrome
6. manifest thyrotoxicosis

Primary outcomes:
measure: Survival
timeFrame: 2 year
measure: Survival
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt Am Main
country: Germany
facility: Institute for experimental and translational cardiovascular imaging
state: Hessen
Study officials:
References:
Clinical trial NCT04394767: Couple and Spouse Caregiver in Huntington's Disease
Official title: Couple and Spouse Caregiver in Huntington's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Huntington Disease
Keywords: Huntington's disease
spouse caregiver
quality of life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Huntington disease population ( patient, caregiver, spouses)

Brief summary: The objectives are to better document the psychosocial status and needs of caregiver of HD patients and understand the dyad functioning, facing the disease at various stages.


Eligibility criteria: Inclusion Criteria:

For patient :

* HD, CAG \> 36, motor UHDRS \> 5
* Being able to communicate with the investigator

For both spouses :

* Living together since at least 5 years
* 30 to 60 years old

Exclusion Criteria:

For patient :

- Other chronic neurologic disorder

For both spouses :

* Psychiatric disease
* Unable to participate, incl read, understand and sign the informed consent

Primary outcomes:
measure: report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease
timeFrame: once time, Baseline
Secondary outcomes:
measure: report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease
timeFrame: once time, Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Clémence Simonin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Pascal ANTOINE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01958567: Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
Official title: Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleritis and Episcleritis
Keywords: Scleritis
Episcleritis
Optical coherence Tomography
Lead sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls.

Detailed description: A total of 40 eyes will be included. 20 eyes with scleral inflammation and 20 eyes from healthy subjects as controls. Each patient will undergo complete ophthalmic and medical examination. Laboratory studies will performed whenever indicated. Optical coherence tomography B-scans of the sclera in the perilimbal area will done for all cases.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 years any gender
* Patients with clinical signs of scleritis or episcleritis
* Signed informed consent

Exclusion Criteria:

* Infectious keratitis or conjunctivitis
* Patients 18 years or younger
* Inability to open the eye

Primary outcomes:
measure: To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: The Eye Center
Study officials:
References:
Clinical trial NCT06391567: Balance in People With Frozen Shoulder
Official title: Determination of Balance Characteristics in People With Frozen Shoulders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frozen Shoulder
Keywords: Adhesive Capsulitis
Balance
Pain
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Physical Medicine and Rehabilitation Outpatient Clinic with complaints of shoulder pain were examined by a physiatrist. Patients who were diagnosed with Frozen Shoulder by physical examination, who met the inclusion criteria, and who agreed to participate in the study were included in the study. The control group consisted of hospital and university staff. The control group was also assessed by the same physiatrist and confirmed by the country's health database as having no chronic disease affecting balance.

Brief summary: The aim of this study was to investigate the balance characteristics of patients with Frozen Shoulder.


Eligibility criteria: Inclusion Criteria:

* Volunteers aged 40-65 years,
* Diagnosed with unilateral Frozen Shoulder, Frozen Shoulder stage 2-3,
* Pain lasting more than 3 months,
* No mental or cognitive impairment
* At least 25% movement limitation in at least 2 movement planes and
* Able to cooperate.

Exclusion Criteria:

* Who had a neurological, rheumatic, cardiac and active malignant diseases
* Who had a history of surgery, trauma, and fracture
* Who had comorbid conditions that would affect balance

The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.

Primary outcomes:
measure: Sociodemographic Form
timeFrame: 8 week
measure: Balance Function
timeFrame: 8 week
measure: Static and Dynamic Postural Balance
timeFrame: 8 week
measure: Pain Intensity
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Atahan TURHAN
state: Merkez
Study officials:
References:
Clinical trial NCT02877667: Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
Official title: Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tattoo
Keywords: tattoo
laser
Lead sponsor: Soliton
Sponsor class: INDUSTRY
Collaborators: name: MedSource LLC
First posted: 2016-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.

Detailed description: A non-significant risk, single center, prospective device trial to evaluate the number of passes of Q-Switch laser treatment that can be completed with a Q-Switch Laser alone compared to use of the Soliton Planar Acoustic Wave Device System (AWD) System as an accessory to Q-switched laser in tattoo reduction treatment.

Eligibility criteria: Inclusion Criteria:

* Range of Fitzpatrick skin color scores I to III
* Tattoo with location on arms, legs, and torso only, and accessible to AWD treatment head. Black ink only. Other ink colors may be present, but areas of black only tattoo should meet criteria described as: minimum 1" x 3" tattoo with at least 30-50% consistent coverage (see fig 1).
* Tattoo age between 1 and 20 years.
* Professionally applied.

Exclusion Criteria:

* Subject is pregnant or planning to become pregnant during the duration of the study.
* Prior tattoo removal procedures on target tattoo.
* Self-applied or amateur tattoo.
* Tattoo layering (additional tattoo placed over an older tattoo to hide it) on target tattoo.
* Metal or plastic implants in the area of the tattoo (pacemaker, implanted defibrillator, stent, or implants in the hips, knees, elbows, etc.).

Primary outcomes:
measure: Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events
timeFrame: 1 day
Secondary outcomes:
measure: Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
Study officials:
affiliation: Soliton
name: Chris Capelli, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03007667: The Impact of Colorectal Cancer Surgery on Localization of Ureters; Prospective Clinical Trail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Relocation of the Ureter After Surgery
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer

Brief summary: To investigate the changes in the anatomical location of ureters after colorectal surgery.


Eligibility criteria: Inclusion Criteria:

1. \>18 years old
2. Curative surgery for colorectal cancer diagnosis

Exclusion Criteria:

1. Abnormal renal function
2. Not having the test in accordance with the cancer follow-up program
3. Contrast allergy
4. Any surgery for the ureters in history

Primary outcomes:
measure: relocation of ureters (milimeters)
timeFrame: 1/10/2016- 1/06/2017
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Koşuyolu Higher Specialization Training and Research Hospital
state: Kartal
Study officials:
References:
Clinical trial NCT02388867: Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization
Official title: Predictive Role of Matrix Metalloproteinases for the Outcome of Surgical Revascularization in Patients With Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Extracellular Matrix Alteration
Peripheral Revascularisation
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In the present study the investigators will evaluate MMPs. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.

Detailed description: Recent clinical studies showed an association between Peripheral Artery Disease (PAD) and circulating levels of Matrix Metalloproteinases (MMPs), especially MMP-2, MMP-9, MMP-8 and MMP-10, compared with healthy controls. A recent study showed the association between MMP-10 serum levels and severity and poor outcome in patients affected by Critical Limb Ischemia (CLI).

Also, MMPs seems to be involved in intimal hyperplasia and constrictive remodeling, both responsible of restenosis after surgical treatment of atherosclerotic lesions.

Intimal hyperplasia is a thickening of the tunica intima resulting in narrowing of the vessel lumen.

Elevated tissue levels of MMP-2 and MMP-9 have been identified in pig models of vein bypass grafts, temporally coinciding with the period of Smooth Muscle Cells (SMC) migration and neointimal formation.

In the present study the investigators want to evaluate MMP-1; MMP-2, MMP-9, MMP-8 and MMP-10 serum levels variations in patients affected CLI, before and after lower limb surgical revascularization through venous or prosthetic bypass in order to assess their role in predicting the surgical outcome of these procedures.

Patients with CLI will be randomized to receive lower limb surgical revascularization through autogenous venous (Group I) or prosthetic bypass (using synthetic polytetrafluoroethylene - PTFE- ) (Group II).

Patients enrolled in the present study will be followed through clinical and ultrasonographic examination at 1, 3, 6, 12 and 24 months. At the same time points MMPs plasma levels (by means of blood sampling through venipuncture) will be evaluated. Clinical, Instrumental and Laboratory data then will be matched.

Eligibility criteria: Inclusion Criteria:

* patients with CLI stage III-IV according to the Fontaine's classification

Exclusion Criteria:

* Patients with evidence of systemic sepsis, known neoplastic disease or any established generalized inflammatory disease

Primary outcomes:
measure: MMPs evaluation
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01263067: Lifespan Integration for Posttraumatic Stress Disorder From an Auto Accident
Official title: Lifespan Integration Therapy for Posttraumatic Stress Disorder of Adults Involved in an Auto Accident
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
PTSD
Car Accident
Auto Accident
Lifespan Integration
Lead sponsor: Argosy University
Sponsor class: OTHER
First posted: 2010-12-20
Enrollment: 6
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: The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma

Detailed description: Studies estimate a substantial proportion of MVA survivors, ranging from 9.4% to 59.9%, will develop PTSD following an accident (Blanchard \& Hickling, 2004). Based on conservative estimates, past research, indicates that MVA-related PTSD may affect 2.5 to 7 million persons in the United States (Blanchard \& Hickling). Furthermore, two seminal epidemiological studies (Kessler et al., 1995; Norris, 1992) that focused on causes of adult PTSD identified MVAs as the most frequent trauma resulting in PTSD. For these reasons, MVA-resultant PTSD represents a significant public health problem that needs not only to be thoroughly understood, but addressed with successful mental health treatment options (Beck \& Coffey, 2007; Blanchard \& Hickling, 1997, 2004; Bryant et al., 1998; Taylor et al., 1999; Taylor et al., 2001). Although there is empirical literature on the treatment of PTSD following an MVA, additional efficacious and rigorously conducted studies with statistical underpinnings are required to determine the results that can be expected from alternative models of care (Beck \& Coffey; Blanchard \& Hickling, 1997, 2004).

Eligibility criteria: Inclusion Criteria:

* Involved in or witnessed a car accident at least 6 months ago.
* PTSD or distress or impairment in important areas of functioning following the car accident

Exclusion Criteria:

* moderate or severe head injury
* current mental health treatment for the MVA-related problem
* severe chronic pre-injury mental health problems

Primary outcomes:
measure: Clinicians Administered PTSD Scale
timeFrame: following the final treatment session (average of 6 weeks from treatment start date)
Secondary outcomes:
measure: Personality Assessment Inventory
timeFrame: following the final treatment session (average of 6 weeks from treatment start date)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Argosy University Seattle
state: Washington
Study officials:
affiliation: Argosy University Seattle
name: Frances Parks, PhD
role: STUDY_CHAIR
References:
citation: Pace, P. (2007). Lifespan integration: Connecting ego states through time (fourth ed.). Roslyn, WA: Peggy Pace.
Clinical trial NCT03804567: Oldpain2go®: an Exploratory (Pre-Feasibility) Study.
Official title: Oldpain2go®: an Exploratory (Pre-Feasibility) Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Keywords: Oldpain2go®
Feasibility
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Research question: Is there any evidence to suggest that the oldpain2go® intervention merits scientific investigation?

Detailed description: Aims:

1. To collect data to:

   1. give an indication of the potential effect size, of any effects, from the oldpain2go® intervention, in people with persistent low back pain.
   2. to explore the eligibility criteria, recruitment methods and materials proposed here, for potential use in a future Feasibility study, of the oldpain2go® intervention.
2. To compare demographic characteristics, medical history and outcome measure data of:

   1. people for whom Oldpain2go® is indicated (at the Oldpain2go® screening session), with those for whom it is not,
   2. people for whom the Oldpain2go® intervention works, after one treatment, with those for whom it does not, and
   3. people for whom the Oldpain2go® intervention works, after one, or two, treatments, with those for whom it does not work after two treatments.

Eligibility criteria: Inclusion Criteria:

* Currently suffering from persistent, non-specific, low back pain
* Aged over 18 years
* For whom Oldpain2go® is indicated as a treatment option after the standard clinical screening process for the Oldpain2go® treatment

Exclusion Criteria:

* Any Red Flags,
* Any causative (or potentially causative) structural abnormality, or pathology detected or suspected
* Any concurrent pathology, or condition that would limit options for Physiotherapy treatment,
* Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent

Primary outcomes:
measure: A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain
timeFrame: Change measures at three points, baseline, 1 week and 2 weeks from baseline
Secondary outcomes:
measure: The Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Change measures at three points, baseline, 1 week and 2 weeks from baseline
Other outcomes:
Locations:
city: Norton
country: United Kingdom
facility: Norton Physiotherapy Centre
state: Stockton-on-Tees
Study officials:
affiliation: Teesside University
name: Alasdair MacSween, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725867: Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
Official title: Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: temporomandibular joint disorder
myofascial pain
manual myofascial release
physical therapy
oral appliance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 49
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
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 compare the effect of physical therapy (PT) program and oral appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).

Detailed description: The details of each intervention are listed as following:

* physical therapy program group (PT): manual myofascial release over craniomandibular system, chin-in exercise and self-care education
* oral appliance group (splint): custom-made stabilization splint and self-care education

Eligibility criteria: Inclusion Criteria:

* (1) 20-65 years old female, (2) diagnosed as MFP subtype of TMD according to Research Diagnostic Criteria for TMD (RDC/TMD), (3) pain duration over 3 month, (4) palpable taut band in masseter, (5) Asymmetrical pain intensity, (6) subsided symptoms of joint inflammation.

Exclusion Criteria:

* (1) traumatic TMD from external impact force, (2) history of traumatic cervical injury, (3) presence of systemic disease, (4) fibromyalgia, (5) co-interventions for cervical problems or TMD during study period, (6) signs of psychosomatic illness, (7) unwilling to be randomized, (8) unable to wear the splint or received intraoral myofascial release, (9)pregnancy.

Primary outcomes:
measure: Pain status
timeFrame: 20 mins
Secondary outcomes:
measure: range of motion (ROM)
timeFrame: 5 mins
measure: muscle strength
timeFrame: 5 mins
measure: muscle endurance
timeFrame: 10 mins
measure: muscle stiffness
timeFrame: 10 mins
measure: Quality of life (QoL)
timeFrame: 15 mins
Other outcomes:
measure: stress
timeFrame: 5 mins
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: