louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00665795: Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy
Official title: Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy Using Multidetector Computed Tomography Scan and Color Doppler Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysthyroid Orbitopathy
Keywords: Dysthyroid Optic Neuropathy
multidetector computed tomography
color doppler
Grave´s Orbitopathy
Grave´s Disease
morphometric analysis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Graves´ orbitopathy

Brief summary: The purpose of this protocol is to study orbital structures in Graves´ Disease using multidetector computed tomography and color doppler imaging.

Some changes in orbital structures detected by imaging exams could predict severity of the ocular Graves´disease. Thus the study could be useful in improve medical management of patients with Graves´ Disease.

Detailed description: Morphometric analysis of orbital structures in Graves´ Orbitopathy using multidetector computed tomography scan and color doppler imaging:

Patients with Graves´ orbitopathy are evaluated by a complete ophthalmic examination.A prospective study with Multidetector CT scan and Color Doppler of these patients are made to develop parameters capable to predict Dysthyroid Optic Neuropathy (DON).

Eligibility criteria: Inclusion Criteria:

* Graves´Orbitopathy diagnosed based on previously reported criteria
* Age above 20 years
* Good cooperation for performing Visual Field test
* Spherical refraction within ± 5 D and cylinder correction within ± 3 D

Exclusion Criteria:

* Graves´Orbitopathy not diagnosed

Primary outcomes:
measure: screening indexes for dysthyroid optic neuropathy
timeFrame: indexes above 60% of orbital apex crowding were high suspected for DON
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: General Hospital - University of Sao Paulo - School of Medicine
Study officials:
affiliation: University of Sao Paulo - School of Medicine
name: Mario L Monteiro, MD, PhD
role: STUDY_CHAIR
References:
citation: Goncalves AC, Silva LN, Gebrim EM, Monteiro ML. Quantification of orbital apex crowding for screening of dysthyroid optic neuropathy using multidetector CT. AJNR Am J Neuroradiol. 2012 Sep;33(8):1602-7. doi: 10.3174/ajnr.A3029. Epub 2012 Mar 22.
Clinical trial NCT02016495: Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2013-12-20
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 41
Standard ages: ADULT

Brief summary: To evaluate whether a combined supplementation of magnesium and lipoic acid is able to significantly reduce the incidence of uterine contractions and related episodes of hospitalization in pregnant women.

Detailed description: Primary prevention of preterm labor is based on the early identification of risk factors and on appropriate treatments. Although several drugs are currently used, the identification of effective and safe agents able to improve both maternal and fetal health is still warranted.

In this study the efficacy a formulation based on magnesium and alpha-lipoic acid has been compared with placebo to evaluate the incidence of reduction of preterm delivery.

Three hundred pregnant women at 14-34 weeks of gestation were enrolled and randomly divided to receive a daily single tablet containing magnesium and alpha-lipoic acid supplement or placebo until delivery.

Eligibility criteria: Inclusion Criteria:

* 14-34 weeks of gestation

Exclusion Criteria:

* Preexisting diabetes mellitus
* Systolic blood pressure \>140mm Hg
* Cancer
* lupus
* hepatitis
* HIV/AIDS
* Diagnosed alcohol or chemical dependency

Primary outcomes:
measure: Number of women with sporadic episodes of preterm uterine contraction
timeFrame: From baseline (beginning of the treatment) until delivery
measure: Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain
timeFrame: From baseline (beginning of the treatment) until delivery
measure: Number of women needed for hospital admission for threatened preterm labour
timeFrame: From baseline (beginning of the treatment) until delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Clinica Villa delle Querce
Study officials:
References:
Clinical trial NCT03013881: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
Official title: Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasm
Keywords: UB-921
anti-HER2 monoclonal antibody
breast neoplasm
breast cancer
Herceptin
Trastuzumab
HER2
Lead sponsor: United BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Tri-Service General Hospital
First posted: 2017-01-09
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.

Detailed description: This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main Study) and comparative pharmacokinetics study (Sub-study).

Eligibility criteria: Inclusion Criteria:

* Total body weight ≧50 kg (110 lbs)
* No clinically relevant abnormalities
* To agree on using birth control barrier (eg. male condom) during the entire study period.
* Signing the written informed consent form

Exclusion Criteria:

* Previous exposure to chimeric, humanized or human monoclonal antibody, whether licensed or investigational
* A history of drug abuse or heavy drinking.
* Blood donation over 250 mL within 90 days prior to the screening
* Not in the condition to participate in this study considered by investigator(s)

Primary outcomes:
measure: Adverse event incidence
timeFrame: 63 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Prime site
Study officials:
affiliation: Tri-Service General Hospital
name: Hsiang-Cheng Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01024881: Influence of the Shoulder Position on the Catheter Tip Location During Infraclavicular Subclavian Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Tip Location
Keywords: catheterization success rate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 344
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Infraclavicular approach of the subclavian veins is commonly used for central venous access. Aberrant locations of catheter tip are frequently quoted for this approach, but few studies have been performed to document the relationship between the shoulder position and catheter tip location. This prospective study was performed to assess the influence of the shoulder position on the safe and proper placement of infraclavicular subclavian catheters.


Eligibility criteria: Inclusion Criteria:

* adult patients requiring central venous catheterization due to major procedures such as neurosurgery or thoracic surgery.

Exclusion Criteria:

* chest deformities,
* coagulopathy,
* diaphragmatic dysfunction,
* pulmonary malformation,
* history of prior clavicle fracture, or
* infection over the puncture site.

Primary outcomes:
measure: location of the catheter tip
timeFrame: at the end of surgery
Secondary outcomes:
measure: catheterization success rate
timeFrame: immediately after catheterization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05607381: Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain
Official title: Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Opioid Use
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 150
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 purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.


Eligibility criteria: Inclusion Criteria:

1) men/women 18-65 years of age; 2) current chronic low back pain classified according to the NIH Pain Consortium task force research standards for chronic low back pain (pain on at least half the days in the past 6 months); usual back pain ≥3 on 0-10 scale with opioid medication; and 4) current use of prescription opioids for ≥3 months.

Exclusion Criteria:

1) Prior experience with MBSR, MBCT, MORE, or extensive involvement in any standardized meditation training, 2) current cancer diagnosis, 3) suicide intent or attempt in the past 30 days, 4) psychosis or moderate/severe non-opioid substance use disorder in past 6 months; 5) persons with any electronic objects or certain metal objects in their head or body that are incompatible with MRI; 6) those who have had an abnormal brain MRI in the past; 7) those unable to lie still on their back for 1 to 1.5 hours; and 8) pregnancy.

Primary outcomes:
measure: Blood oxygenation level dependent (BOLD) signaling
timeFrame: At baseline and at post-treatment (8 weeks)
Secondary outcomes:
measure: Visual Analog Scale Pain Ratings
timeFrame: At baseline and at post-treatment (8 weeks)
measure: Chronic pain symptoms
timeFrame: At baseline, post-treatment (8 weeks), and 3-month follow-up
measure: Opioid dose
timeFrame: At baseline, post-treatment (8 weeks), and 3-month follow-up
measure: Pain catastrophizing
timeFrame: At baseline, post-treatment (8 weeks), and 3-month follow-up
measure: Self-transcendence
timeFrame: At baseline, post-treatment (8 weeks), and 3-month follow-up
measure: Mindful reinterpretation of pain sensations
timeFrame: At baseline, post-treatment (8 weeks), and 3-month follow-up
measure: Trait mindfulness
timeFrame: At baseline, post-treatment (8 weeks), and 3-month follow-up
Other outcomes:
measure: Heart rate variability
timeFrame: At baseline and at post-treatment (8 weeks)
measure: Cue-reactivity
timeFrame: At baseline and at post-treatment (8 weeks)
Locations:
city: Salt Lake City
country: United States
facility: Center on Mindfulness and Integrative Health Intervention Development
state: Utah
Study officials:
affiliation: University of Utah
name: Eric Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01651481: Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination
Official title: Open-label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics and Safety of Singulair (10 mg) and Xyzal (5 mg) in Free Combination and Fixed-dose Combination as HCP1102 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rhinitis
Keywords: Rhinitis
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg) and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102


Eligibility criteria: Inclusion Criteria:

* Healthy male
* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypotension or hypertension
* Has a history of acute infection within 14 days of screening

Primary outcomes:
measure: AUClast
timeFrame: 0-34hr
measure: Cmax
timeFrame: 0-34hr
Secondary outcomes:
measure: tmax
timeFrame: 0-34hr
measure: AUCinf
timeFrame: 0-34hr
measure: t1/2
timeFrame: 0-34hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
Clinical trial NCT05676281: Healing Experiences of Adversity Among Latinos (HEALthy4You)
Official title: Healing Experiences of Adversity Among Latinos (HEALthy4You)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Childhood Obesity
Keywords: ACEs
Obesity
Adverse Childhood Experiences
2x2 Factorial Study
Behavioral Intervention
Health Education
Healthy Together
Parenting
Protective Factors
Precision Medicine
Federally Qualified Health Centers
Latino
Hispanic
Pediatric
Whole Child Wellness
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Family Health Centers of San Diego
name: UCSD Center for Community Health
First posted: 2023-01-09
Enrollment: 240
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Healing Experiences of Adversity Among Latinos (HEALthy4You) is a project funded by the California Initiative for the Advancement of Precision Medicine ("Advancing a Precision Population Health Approach to ACEs to Reduce Health Disparities"). The long-term goal of this project is to develop community-centered, culturally Appropriate, precision Interventions that can be delivered within Federally Qualified Healthcare Centers (FQHCs) for Latino Families, to reduce Adverse Child Events (ACES) risks and treat childhood obesity. UCSD in conjunction with Family Health Centers of San Diego (FHCSD) will conduct a 2x2 factorial trial with four groups meant to determine what combination of intervention components influence family protective factors (a key marker for reduced risk of the deleterious effects of systemic and family/individual stressors that are a critical part of ACEs) and childhood obesity.


Eligibility criteria: Inclusion Criteria:

* Child
* Currently a patient at Family Health Centers of San Diego
* Age 5-11 years old
* BMI ≥ 85th percentile to 99.9th percentile
* Social determination or risk for ACE determined as being a patient receiving care at an FQHC (confirmed via provider)
* Parent
* Parent or guardian (including non-biological parent or relative) willing to participate
* Self-identification as Hispanic or Latino
* 18 years or older
* English or Spanish speaking
* Willingness to commit to 6 months of the program

Exclusion Criteria:

* Serious Developmental Disability (parent or child)
* Serious Mental Health Illness (parent or child)

Primary outcomes:
measure: Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)
timeFrame: 6 months
Secondary outcomes:
measure: Changes to Child Body Mass Index (BMI) from baseline to 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Family Health Centers of San Diego
state: California
city: San Diego
country: United States
facility: Jessica Chapman
state: California
Study officials:
References:
Clinical trial NCT05708781: Efficacy of Core Strengthening and Intensive Dynamic Back Exercises in Patient With Low Back Pain
Official title: Efficacy of Core Strengthening and Intensive Dynamic Back Exercises on Pain, Muscle Strength, Endurance, and Functional Disability in Patients With Chronic Non-specific Low Back Pain. a Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Najran University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain.

Detailed description: The study will be based on a three-arm parallel group randomized control design. Forty-five participants with chronic non-specific low back pain will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups A, B, and C. Experimental group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and core strengthening exercises while group B will receive the hot pack, active Stretching, isometric exercise intervention, and intensive dynamic back exercises, control group C will receive the hot pack, active Stretching, isometric exercise intervention.

Eligibility criteria: Inclusion Criteria:

* age 20-50 years
* chronic low back pain (\>3 months),

Exclusion Criteria:

* Participants with low back pain related to cancer,
* infection,
* inflammatory arthropathy,
* high-velocity trauma,
* fracture
* low back pain associated with severe or progressive neurological deficits trauma
* pregnancy.

Primary outcomes:
measure: Pain Intensity
timeFrame: 6 Weeks
measure: functional Limitation
timeFrame: 6 Weeks
measure: Muscle Endurance
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Integral University Hospital
state: Uttar Pardesh
city: Najrān
country: Saudi Arabia
facility: Hashim Ahmed
state: Najran
Study officials:
affiliation: Najran University
name: Hashim Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01622881: Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation
Official title: Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation : Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators examined the efficacy of nefopam in patients undergoing kidney transplantation.

Detailed description: Drug combination are frequently used to relieve postoperative pain. Nefopam can inhibit serotonin, dopamine, and norepinephrine reuptake through central mechanisms. Several studies have demonstrated analgesic efficacy of nefopam in the postoperative period. The purpose of this study is to ascertain the analgesic effect and tolerance of intravenous nefopam in combination with fentanyl based patient-controlled analgesia after kidney transplantation.

Eligibility criteria: Inclusion Criteria:

* elective living donor kidney transplantation

Exclusion Criteria:

* pre-operative tachycardia (\> 100bpm)
* liver dysfunction
* severe cardiac disease
* body mass index ≥ 30 kg/m2
* drug allergy

Primary outcomes:
measure: Fentanyl consumption by patient-controlled analgesia
timeFrame: 48 hours
measure: Numerical rating score of pain
timeFrame: 48 hours
Secondary outcomes:
measure: The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia)
timeFrame: 48 hours
measure: Early postoperative graft function
timeFrame: until discharge
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02943681: A Second Dose of Measles Vaccine (MV) in the Second Year of Life
Official title: Boosting the Beneficial Non-specific Effects of Live Attenuated Vaccines: A Randomized Controlled Trial (RCT) of a Second Dose of Measles Vaccine (MV) in the Second Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Mortality
Child Morbidity
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 3812
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.

Exclusion Criteria:

* Having severe malformations that impairs their health
* Having received a second dose of measles vaccine
* Severely ill (requiring hospitalization) upon clinical examination

Primary outcomes:
measure: Mortality
timeFrame: 30 months
measure: Hospital admissions
timeFrame: 30 months
Secondary outcomes:
measure: Hospital admission by cause
timeFrame: 30 months
measure: Consultations
timeFrame: 30 months
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project, Apartado 861
Study officials:
References:
citation: Berendsen MLT, Silva I, Bale C, Nielsen S, Hvidt S, Martins CL, Benn CS, Aaby P. The Effect of a Second Dose of Measles Vaccine at 18 Months of Age on Nonaccidental Deaths and Hospital Admissions in Guinea-Bissau: Interim Analysis of a Randomized Controlled Trial. Clin Infect Dis. 2022 Oct 12;75(8):1370-1378. doi: 10.1093/cid/ciac155.