louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00933764: Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiovascular Disease
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 0
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: Individuals being assessed of their risk of cardiovascular disease. Patients can currently be diagnosed with cardiovascular disease.

Brief summary: This is a multi-center study designed to assess the accuracy and precision of the Cholestech LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in whole blood, serum and plasma from individuals being assessed for risk of cardiovascular disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer and measures CRP with high sensitivity on fingerstick or venous whole blood at the point-of-care (POC). The results of this study are intended to be used for regulatory 510k filings for use as an in vitro diagnostic test.


Eligibility criteria: Inclusion Criteria:

1. Adults (18 years of age or older) presenting to their physician's office or outpatient clinic for routine or pre-scheduled visits and a candidate for cardiovascular risk assessment.
2. Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria:

1. Known hematocrit \<30% or \> 52%;
2. History of medical conditions - other than risk of cardiovascular disease - that may elevate CRP as listed in Appendix B (e.g., tissue damage, infection, inflammation, malignant neoplasia)
3. Vulnerable populations deemed inappropriate for study by the site's principal investigator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: St. Joseph's Research Institute
state: Georgia
city: Petoskey
country: United States
facility: Heart and Vascular Research Center of Northern Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT04057664: A Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic and Chronic Belly Pain
Official title: Managing the Pain - a Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic Pain and Chronic Belly Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain, Chronic
Pain, Pelvic
Pain, Abdominal
Depression
Sex Disorder
Endometriosis
Keywords: Coping
Multidisciplinary
Group Therapy
Psychotherapy
Physiotherapy
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2019-08-15
Enrollment: 35
Sex: FEMALE
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: Women with chronic pelvic or belly pain, participating in our multimodal group therapy

Brief summary: The project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy.

Detailed description: To treat patients with chronic pelvic and belly pain in an interdisciplinary way, we developped a group therapy consisting of twelve sessions and a booster session. The therapy is based on the bio-psycho-social model of pain and includes group sessions of psychotherapy as well as physiotherapy.

All patients fill in questionnaires (concerning pain impact, pain chronicity, depression, anxiety, stress, well-being and sexuality) before and after the therapy as well as three and twelve months after.

Eligibility criteria: Inclusion Criteria:

Women with chronic pelvic pain or belly pain participating in our group therapy who give their consent to the analysis of their data for the study

Exclusion Criteria:

* No participation in the group therapy
* Finishing the group therapy prematurely (\>3 missed sessions)

Primary outcomes:
measure: Change in Pelvic Pain Impact Questionnaire (PPIQ)
timeFrame: baseline, 6 weeks, 3 months, 12 months
Secondary outcomes:
measure: Change in Sexual Functioning Questionnaire (CSFQ-14)
timeFrame: baseline, 6 weeks, 3 months, 12 months
measure: Change in Female Sexual Distress Scale-Revised (FSDS-R)
timeFrame: baseline, 6 weeks, 3 months, 12 months
measure: Change in Chronic Pain Grade Scale (CPGS)
timeFrame: baseline, 6 weeks, 3 months, 12 months
measure: Change in Depression
timeFrame: baseline, 6 weeks, 3 months, 12 months
measure: Change in Anxiety
timeFrame: baseline, 6 weeks, 3 months, 12 months
measure: Change in Stress
timeFrame: baseline, 6 weeks, 3 months, 12 months
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Center of Pain Medicine
state: LU
Study officials:
References:
Clinical trial NCT05500664: The Effect of Aromatherapy on Anxiety in Patients
Official title: The Effect of Aromatherapy on Anxiety in Patients Undergoing Genicular Nerve Radiofrequency for Painful Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We hypothesized that the use of lavender aromatherapy before surgery would reduce preintervntion of radiofrequency anxiety as assessed by the Speilberger State-Trait Anxiety Inventory (STAI) questionnaire
Primary purpose: PREVENTION

Brief summary: Preoperative anxiety is considered a potential and preventable risk factor for postoperative complications.

Detailed description: Alot of patients face fear from intervention such as radiofrequency. The group of patients with chronic knee osteoarthritis already and mostly have some sore of psychological upset, radiofrequency itself , even in the presence of good periinterventional local anesthetic infiltration, the patients suffer pain and stress. It is well evidenced that aromatherapy specially with Lavender oil offers some sort of anxiety alleviation, pain alleviation and protection against postoperative nausea and vomiting

Eligibility criteria: Inclusion Criteria:

* adult patients with knee osteoarthritis
* scheduled for genicular nerve radiofrequency

Exclusion Criteria:

* Allergy to lavender
* psychological disorders
* upper respiratory tract illness

Primary outcomes:
measure: change of Speilberger State-Trait Anxiety Inventory
timeFrame: preintervention, 15 minutes postintervention
Secondary outcomes:
measure: change of Pain visual analog scale
timeFrame: Preintervention, 15 minutes postintervention
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT06653764: Chest Physiotherapy and Aerobic Training in Children Post Abdominal Surgery
Official title: Effects of Chest Physiotherapy and Aerobic Exercise Training in Improving Physical Fitness InYoung Children Post Abdominal Surgery: an Experimental Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Abdominal Surgery
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2024-10-22
Enrollment: 23
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will underscore the clinical importance of integrating chest physiotherapy and aerobic exercise training into the post-abdominal surgery care regimen for young children.By improving physical fitness levels, these interventions contribute significantly to the overall recovery process and enhance the well-being of pediatric patients. Implementing such strategies can optimize functional outcomes, reduce complications, and promote a faster return to normal activities, thereby improving the quality of life for young patients undergoing abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Age from 5 Years to 15 Years, Gender: Both, Details: Children who underwent abdominal surgery, having stable vitals, admitted in PICU and pediatric wards

Exclusion Criteria:

* Patients with severe neurological illness, uncooperative patients, comatose patients, patients who are unwilling to enroll in study

Primary outcomes:
measure: Spirometey, manual muscle testing
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roorkee
country: India
facility: Arogyam Institute ofParamedical and AlliedSciences
state: Uttaranchal
Study officials:
References:
Clinical trial NCT05339464: Ready and Healthy for Kindergarten
Official title: Ready and Healthy for Kindergarten- Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Language Development
Literacy
Health Behavior
Keywords: Early literacy
Language development
Family literacy
Bilingualism
Community engagement
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-04-21
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study pilot tests a family wellness program that promotes academic and physical readiness for school among Latino dual language learners using a mixed methods and community engaged approach.

Detailed description: The investigators propose a pilot randomized controlled trial with wait list control to pilot test a family wellness program designed for Latino dual language learners entering Kindergarten and their families. The investigators will recruit up to 48 parent-child dyads to participate in the study. Families will be randomly assigned to session one beginning in June 2022 or session two beginning in July 2022. The investigators will examine the feasibility and acceptability of the family wellness program as well as preliminary effects on parenting behaviors and child language and literacy skills.

Eligibility criteria: Inclusion Criteria:

* Primary caregiver of a child entering Kindergarten (4-6 years old),
* Primary caregiver identifies as Hispanic/Latino/Latinx,
* Family speaks Spanish at home,
* Cell phone ownership,
* Willing to receive texts, and
* Willing to accept randomization

Exclusion Criteria:

* Children with multiple congenital anomalies or genetic disorders and previously identified developmental delays will be excluded.

Primary outcomes:
measure: Number of sessions attended
timeFrame: 2months
measure: Acceptability assessed by the Acceptability of Intervention Measure (AIM)
timeFrame: 2 months
Secondary outcomes:
measure: Home learning environment
timeFrame: Enrollment, 2months, 4months
measure: Child vocabulary
timeFrame: Enrollment, 2months, 4months
measure: Child literacy skills
timeFrame: Enrollment, 2 months, 4 months
measure: Home health routines
timeFrame: Enrollment, 2 months, 4 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Child Health Institute
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Manuel Jimenez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321164: Fumaric Acid Versus Fumaric Acid Plus Narrow Band Type B Ultraviolet (UVB) for Psoriasis
Official title: Fumaric Acid Esters Versus Fumaric Acid Esters Plus Narrow Band Type B Ultraviolet (UVB) in Patients With Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to evaluate the additional effect of a narrow band Type B Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a positive predictive factor for the treatment response.


Eligibility criteria: Inclusion Criteria:

* Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10)
* Age between 18 and 80 years old

Exclusion Criteria:

* pregnant woman and satisfying women
* cancer, chronic infections, autoimmune diseases
* gastrointestinal illnesses
* liver diseases
* renal malfunctions

Primary outcomes:
measure: Mean reduction in Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Mean cumulative FAE dose required to reach PASI 75
timeFrame: 6 months
measure: Mean reduction in Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline and 6 months
measure: Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)
timeFrame: Baseline and 6 months
measure: Mean reduction in Dermatology Life Quality INDEX (DLQI)
timeFrame: Baseline and 6 months
measure: Mean white blood cells (Leukocytes and Lymphocytes) count
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna; Department of Dermatology
Study officials:
affiliation: Medical University of Vienna, Department of Dermatology, Division of General Dermatology
name: Adrian Tanew, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05829564: Virtual Reality and Cervical Mobilization
Official title: Comparison of the Effects of Virtual Reality and Cervical Mobilization in Individuals With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Virtual Reality
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 52
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: The aim of this study is to compare the effects of virtual reality and cervical mobilization on proprioception, balance parameters, pain, disability level, quality of life and overall felt effect in individuals with chronic neck pain. In addition, it is aimed to qualitatively evaluate the virtual reality perspectives of individuals with chronic neck pain.


Eligibility criteria: Inclusion Criteria:

* Neck pain persisting for at least 3 months
* Being between the ages of 18-65,
* Being sedentary (not included in any physical therapy program in the last 6 months), -\>10 points from the Neck Disability Index

Exclusion Criteria:

* History of previous spinal surgery
* Neurological, cardiopulmonary, musculoskeletal disease affecting physical performance
* Any pathology in the shoulder joint
* Spinal trauma history
* Pregnancy

Primary outcomes:
measure: Joint position sense error
timeFrame: Change from Baseline balance after 4 weeks/10 sessions.
measure: Baropodometer assessments-Pressure distribution
timeFrame: Change from Baseline proprioception after 4 weeks/10 sessions.
measure: Baropodometer assessments- Center of gravity
timeFrame: Change from Baseline proprioception after 4 weeks/10 sessions.
measure: Baropodometer assessments- Oscillations
timeFrame: Change from Baseline proprioception after 4 weeks/10 sessions.
measure: Baropodometer assessments- Sway velocity
timeFrame: Change from Baseline proprioception after 4 weeks/10 sessions.
measure: Functional Balance
timeFrame: Change from Baseline proprioception after 4 weeks/10 sessions.
Secondary outcomes:
measure: Cervical Pain
timeFrame: Change from Baseline cervical pain after 4 weeks/ 10 sessions.
measure: Functional disability
timeFrame: Change from Baseline functional disability after 4 weeks/ 10 sessions.
measure: quality of life about cervical pain
timeFrame: Change from Baseline quality of life about cervical pain after 4 weeks/ 10 sessions.
measure: Global perceived effect
timeFrame: Change from Baseline Global perceived effect after 4 weeks/ 10 sessions.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Oge
role: STUDY_DIRECTOR
References:
Clinical trial NCT04543864: Soft Tissue Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Casted
Official title: Soft Tissue Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Casted One (RCT, Split Mouth Design)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparing the changes in the soft tissue around the implants that will be joined by a metal framework either with electric welding or with the conventional casting method

Detailed description: as joining multiple implants by a metal framework considered a solid solution for edentulous arches , but in the same time the conventional method to weld this metal framework to the implants by casting technique in lab usually involves a several disadvantages eg. cost and time consuming in addition to laboratory errors, Thus , this study aims to find another method to weld the metal framework intraorally by an electric welding device

Eligibility criteria: Inclusion Criteria:

* Ages range from 45 to 65 years old.
* Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
* The patients must be completely edentulous.
* The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
* Patients with good oral hygiene.
* Complete denture wearer.
* Adequate inter arch space for screw retained prosthesis.
* Absence of any intra-oral pathological condition.

Exclusion Criteria:

* Patients with recent extraction(less than three months).
* Patients with inflamed ridge or candida infection.
* Patients with flappy ridge.
* Parafunctional habits.

Primary outcomes:
measure: Soft Tissue Changes Assessment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University , Faculty of dentistry
Study officials:
References:
Clinical trial NCT05479864: Single Level Anterior Cervical Corpectomy Without Posterior Stabilization
Official title: Single Level Anterior Cervical Corpectomy Without Posterior Stabilization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spine Fusion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: evaluate and assess short term outcome of treating degenerative and non-degenerative cervical conditions with single level anterior cervical corpectomy without posterior fusion

Detailed description: Cervical corpectomy is a procedure that removes damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves. Various graft materials or spacers are used to maintain height and stability followed by anterior plating. It has an important role in the management of various degenerative, traumatic, neoplastic and infectious disorders of cervical spine.

While ACCF effectively decompresses the spinal cord, it is debated whether it can provide enough cervical stability, or an additional posterior fixation (PF) is required. Studies show that in multi-level anterior cervical corpectomy, additional posterior fixation provides extra support to improve cervical stability whether it is performed initially, or later as a supplementary surgery if material failure or instability occurred, On the other hand, in single level corpectomy, it remains controversial as single level ACCF showed sufficient stability in the majority of cases without additional support but pathologies affecting bone quality like infections and neoplasms seemed to be risk factor for construct failure and instability so additional PF was required .

Eligibility criteria: Inclusion Criteria:

- All patients with degenerative and non-degenerative cervical conditions (trauma, tumors and infections) treated with "single level anterior cervical corpectomy without posterior fusion

Exclusion Criteria:

* Patients who refuse to participate in the study
* Patients who are not available for 6 months follow up

Primary outcomes:
measure: Radiological parameter
timeFrame: Baseline
Secondary outcomes:
measure: Physiological parameter
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Nouri A, Tetreault L, Singh A, Karadimas SK, Fehlings MG. Degenerative Cervical Myelopathy: Epidemiology, Genetics, and Pathogenesis. Spine (Phila Pa 1976). 2015 Jun 15;40(12):E675-93. doi: 10.1097/BRS.0000000000000913.
citation: Perez-Cruet MJ, Samartzis D, Fessler RG. Anterior cervical discectomy and corpectomy. Neurosurgery. 2006 Apr;58(4 Suppl 2):ONS-355-9; discussion ONS-359. doi: 10.1227/01.NEU.0000205285.20336.C2.