louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03123705: El Paso Public Health Biorepository
Official title: TTUHSC El Paso Public Health Biorepository (Research Core Laboratories Dental Biorepository)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Disease
Bacterial Disease
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
Collaborators: name: The City of El Paso Department of Public Health
First posted: 2017-04-21
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients between the ages of 10-21.

Brief summary: The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva from children and young adults to study oral infections, markers of inflammation, and other contributors to oral illnesses in Mexican-American individuals.

Detailed description: As per summary above.

Eligibility criteria: Inclusion Criteria:

* Individuals seen at the City of El Paso dental or pediatric clinics ages 10-21
* Healthy children and patients that are likely to be seen in the clinics within the predetermined follow-up time of 6 months

Exclusion Criteria:

* Patients under 10 years of age and over 21 years of age.

Primary outcomes:
measure: Creation of saliva bio-repository
timeFrame: Through study completion, an average of 3 years
measure: The study of oral bacteria
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center, El Paso
name: Peter S Rotwein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04738305: Feasibility of Dignity Therapy Intervention on Cancer Patients in Charge to an Hospital Palliative Care Unit.
Official title: Feasibility and Acceptability of a Dignity Therapy Intervention on Palliative Care Program's Cancer Patients Referring to a Medical Oncology Ward.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dignity
Advanced Cancer
Keywords: Hospital palliative care unit
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2021-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of the study was to asses feasibility and acceptability of a nurse delivered Dignity Therapy (DT) intervention on advanced cancer patients referring to an Hospital palliative care unit. To achieve this aim a mixed-method approach using before and after evaluation and semi-structured interviews has been used.


Eligibility criteria: Inclusion Criteria:

* advanced cancer patients
* over 3 months life expectancy
* referring to hospital palliative care unit
* performance status (Eastern Cooperative Oncology Group - ECOG) between 0 and 2
* awareness of being affected by an incurable cancer
* cognitive ability to read, understand and fill in a questionnaire in Italian
* willing and able to give written informed consent

Exclusion Criteria:

* \< 18 years old

Primary outcomes:
measure: Enrollment rate
timeFrame: 1 year
measure: Retention rate
timeFrame: 1 year
measure: Professionals' experience in implementing DT
timeFrame: 12-18 months
Secondary outcomes:
measure: Patient dignity-related
timeFrame: Baseline; day 62
measure: Patient feedback
timeFrame: day 62
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda USL - IRCCS di Reggio Emilia
Study officials:
affiliation: Azienda USL - IRCCS di Reggio Emilia
name: Francesca Nunziante
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chochinov HM. Terapia della dignità: parole per il tempo che rimane. Il pensiero scientifico, 2015.
citation: Nunziante F, Tanzi S, Alquati S, Autelitano C, Bedeschi E, Bertocchi E, Dragani M, Simonazzi D, Turola E, Braglia L, Masini L, Di Leo S. Providing dignity therapy to patients with advanced cancer: a feasibility study within the setting of a hospital palliative care unit. BMC Palliat Care. 2021 Aug 16;20(1):129. doi: 10.1186/s12904-021-00821-3.
Clinical trial NCT01849705: Melanocortin 4 Receptor Mutations and Obesity-associated Diseases
Official title: Mutations in the Melanocortin 4 Receptor and Obesity-associated Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
MC4R
Blood pressure
Blood glucose
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rhythm Pharmaceuticals, Inc.
First posted: 2013-05-08
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women aged 18-70 years

Brief summary: Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic obesity, and can explain 2-6% of severe obesity.

Studies have shown that mutations in MC4R are associated with increased fat mass, height-for-age, appetite and insulin resistance among children. In adults, mutations in MC4R are less penetrant for these phenotypes but it has been observed that individuals with MC4R mutations have a smaller than expected blood pressure for their degree of obesity.

The purpose of this study is to explore the association between functional MC4R mutations and obesity, insulin resistance and blood pressure.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* Men and women
* BMI \> 30 kg/m\^2

Exclusion Criteria:

* Uncontrolled type 2 diabetes
* Bariatric surgery
* Use of anti-obesity medication

Primary outcomes:
measure: Blood pressure
timeFrame: Baseline
Secondary outcomes:
measure: Obesity
timeFrame: Baseline
measure: Blood glucose
timeFrame: Baseline
measure: MC4R mutations
timeFrame: Baseline
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
state: Frederiksberg C
Study officials:
affiliation: Department of Human Nutrition, University of Copenhagen
name: Arne Astrup, MD, Dr. Med
role: STUDY_DIRECTOR
affiliation: Department of Human Nutrition, University of Copenhagen
name: Lesli H Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00795405: Cardiovascular Effects of Sporting Events
Official title: Cardiovascular Effects of Major Sporting Events in Subjects With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Coronary Heart Disease
Keywords: sporting events
stress
myocardial ischemia
ST-segment depression
blood pressure
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: China National Center for Cardiovascular Diseases
First posted: 2008-11-21
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Major sporting events may have adverse cardiovascular effects in subjects with coronary heart disease. We also hypothesized that the adverse cardiovascular effects of sporting events are a result of psychobiological processes including stress-induced hemodynamic changes, autonomic dysfunction and parasympathetic withdrawal, and inflammatory and prothrombotic responses, all of which may in turn promote myocardial ischemia.

Detailed description: Observational studies suggest that exposure to sporting events may worsen symptoms of angina and trigger acute myocardial infarction. The mechanisms for this association are unknown. To date, there have been no controlled exposures in patients with coronary heart disease: an important population who may be particularly susceptible to the adverse cardiovascular effects of sporting events.

In a randomized crossover controlled study, 38 patients with prior myocardial infarction will be exposed to sporting events or not. Myocardial ischemia will be quantified by ST-segment analysis using continuous 12-lead electrocardiography, and blood pressure change will be analyzed using ambulatory blood pressure monitoring. Autonomic function will be assessed by heart rate variability. Ischemic, inflammatory and prothrombotic markers will also be measured.

Eligibility criteria: Inclusion Criteria:

* Previous myocardial infarction (\>6 months previously)treated by coronary revascularization
* On standard secondary preventative therapy

Exclusion Criteria:

* Angina pectoris (Canadian Cardiovascular Society grade ≥2)
* History of arrhythmia
* Uncontrolled hypertension
* Unstable coronary disease (acute coronary syndrome or unstable symptoms within 3 months)
* Occupational exposure to sporting events
* Diabetes
* Hepatic or renal failure

Primary outcomes:
measure: Evidence of definite myocardial ischemia confirmed by Holter monitoring
timeFrame: 2 months
measure: Blood pressure measured by ambulatory blood pressure monitoring
timeFrame: 2 months
measure: Heart rate variability
timeFrame: 2 months
Secondary outcomes:
measure: Episode of angina
timeFrame: 3 months
measure: Episode of neurological events
timeFrame: 3 months
measure: Episode of arrhythmia
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cardiovascular Institue and Fuwai Hospital
name: Shengshou Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01957605: Mean Systemic Pressure Measurement During Prone Position Surgery
Official title: Study of Hemodynamic Variations During Prone Position Surgery: Measurement of Mean Systemic Pressure and Venous Return Resistance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodynamic Variation During Surgery
Keywords: prone position
hemodynamic variation
mean systemic pressure
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient scheduled for neurosurgery in the prone position

Brief summary: Venous return is driven by the pressure gradient between mean systemic pressure and right atrial pressure. However, mean systemic pressure is more a physiological concept than an available clinical measurement. Indeed, the mean systemic pressure is the one that would be measured anywhere within the vascular system after cardiac arrest. Recent advances in hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac output measurements during respiratory pauses under mechanical ventilation. In this way, it is possible to calculate MSP, the pressure gradient and the venous return resistances. The investigators aim is to explain the hemodynamic variations and the decrease in cardiac output observed during prone position. The investigators hypothesis is that venous return resistances are increased during prone position probably following an increased intra-abdominal pressure.


Eligibility criteria: Inclusion Criteria:

* Prone position neurosurgery
* High-risk neurosurgery

Exclusion Criteria:

* Emergency surgery
* Pregnancy

Primary outcomes:
measure: mean systemic pressure variation
timeFrame: during surgery after the patient is put in prone position
Secondary outcomes:
measure: intrathoracic pressure variation
timeFrame: during surgery during surgery after the patient is put in prone position
measure: intravesical pressure variation
timeFrame: during surgery during surgery after the patient is put in prone position
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
Study officials:
affiliation: University Hospital of Strasbourg
name: Julien Pottecher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06097897: Imaging of Vitreous Opacities in Human Eyes
Official title: Evaluation of a Non-Invasive Imaging Device for the Acquisition of Imaging Data of Vitreous Opacities in Human Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Floaters
Vitreous Opacities
Lead sponsor: PulseMedica
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Vitreous opacities (VOs), commonly known as floaters, are dark spots that appear in, and may float across your vision. Presently, there is a lack of available data in the literature regarding VOs. This study aims to obtain imaging data of VOs in the population to build an imaging database of VOs to learn more about them.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* SVO-related symptoms in vision
* Clear ocular media, to allow a clear view of the vitreous for the SVO-ID

Exclusion Criteria:

* Presence of vitreous hemorrhage
* Cataract Grade 3 and above
* Opacification of lens, cornea, or vitreous
* Diagnosis of narrow-angle glaucoma
* Refractive error is outside the range of -6D to +3D
* Astigmatism is outside the range of +/- 2D of cylinder

Primary outcomes:
measure: Successful capture of SLO and OCT imaging data of SVOs for algorithm development
timeFrame: Through study completion, an average of one year
Secondary outcomes:
measure: Collection of patient-reported symptoms
timeFrame: Through study completion, an average of one year
Other outcomes:
Locations:
city: Panamá
country: Panama
facility: Panama Eye Center
Study officials:
References:
Clinical trial NCT02821897: Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation
Official title: Value of Target-controlled Intravenous Anaesthesia (TCIVA) to Optimize Coverage of the Low Back Pain Territory in Patients With Chronic Refractory Postoperative Multifocal Low Back and Legpain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 15
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: Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted with a multicolumn lead.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years and ≤ 80 years
* FBSS
* Radicular leg et lumbar pain
* For more than 3 months after one or many spine surgeries
* Mixt pain (radicular leg et lumbar) with Neuropathic status
* Failure of conservative treatment
* Severe uni or bilateral radicular pain \> 5 / 10

Exclusion Criteria:

* Age \<18 years and\> 80 years.
* BMI \> 30 kg/m2.
* Back pain that can be treated by surgery (discogenic, vertebral instability, ...)
* Contraindication to TCIVA anesthesia under propofol remifentanil
* Psychiatric status
* Cancer
* No signature of informed consent.
* Women of childbearing without contraception

Primary outcomes:
measure: Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
state: Worldwide
Study officials:
References:
Clinical trial NCT04713397: Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics
Official title: Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leg Length Inequality
Scoliosis
Pelvic Obliquity
Keywords: Leg Length Discrepancy
Adolescent Idiopathic Scoliosis
Leg Length Discrepancy Scoliometer Test
Lead sponsor: Halic University
Sponsor class: OTHER
Collaborators: name: Medipol University
name: Dokuz Eylul University
name: Başakşehir Çam & Sakura City Hospital
First posted: 2021-01-19
Enrollment: 47
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 to 18 years scoliotic patients diagnosed with structural LLD

Brief summary: The aim of this retrospective study is to present clinical and radiological features and their relationships for differentiating functional scoliosis due to LLD and LLD concurrent with AIS.

Detailed description: This study was conducted as a single-center retrospective comparative study on 47 consecutive scoliosis patients detected LLD, aged 10-18 years, between 2018 and 2020. The scoliosis patients with a diagnosis of structural LLD were divided into two groups according to whether there was a concurrent AIS diagnosis or not. Demographic data were recorded. Limb length was clinically measured by direct, indirect evaluation method and new LLD-Scoliometer Test. Cobb degree, axial rotation, internal/external pelvic obliquity and LLD were obtained from posteroanterior spine radiographs measured by two blinded orthopaedic spine surgeons.

Eligibility criteria: Inclusion Criteria:

* Between December 2018-2020
* Scoliotic patients, who detected LLD
* Ages 10 to 18 years
* Patients who have two or more clinical records at least 6 months apart
* Who accepted to participate in the study.

Exclusion Criteria:

* Neurological disease
* A history of spinal surgery/tumors
* The diagnosis of AIS without LLD or trauma

Primary outcomes:
measure: Full spine PA radiography
timeFrame: baseline
measure: direct evaluation- tape measure
timeFrame: baseline
measure: indirect evaluation- wooden blocks
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Formed Healthcare Scoliosis Treatment and Brace Center
state: Sisli
Study officials:
affiliation: Medipol University
name: Ahsen Büyükaslan, PT, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Başakşehir Çam & Sakura City Hospital
name: Kadir Abul, MD
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Haluk Berk, MD, Prof.
role: STUDY_DIRECTOR
affiliation: Halic University
name: Hürriyet Yilmaz, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Buyukaslan A, Abul K, Berk H, Yilmaz H. Leg length discrepancy and adolescent idiopathic scoliosis: clinical and radiological characteristics. Spine Deform. 2022 Mar;10(2):307-314. doi: 10.1007/s43390-021-00417-0. Epub 2021 Sep 28.
Clinical trial NCT05226897: Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of YYC405-T Added to Metformin and Dapagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With the Combination of Metformin and Dapagliflozin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 256
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel group
Primary purpose: TREATMENT

Brief summary: Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Detailed description: Phase 3 study to assess the Efficacy and Safety of YYC405-T when added to Metformin and Dapagliflozin combination therapy in patients with type 2 diabetes mellitus who have inadequate glycemic control

Eligibility criteria: Inclusion Criteria:

* Patient who contsent to participate in this tiral by written informed consent form
* A man or woman over 20 years old
* Type 2 Diabetes patients

Exclusion Criteria:

* Patients with severe renal impairment, end-stage renal disease or on dialysis
* Type 1 diabetes patients
* Patients with a history of acute or chronic target acidosis, including lactic acidosis and diabetic ketoacidosis

Primary outcomes:
measure: HbA1c
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: Baseline, 12weeks
measure: FPG, Fasting insulin
timeFrame: Baseline, 12weeks, 24weeks
measure: C-peptide
timeFrame: Baseline, 12weeks, 24weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea(Bucheon St. Mary's Hospital)
Study officials:
affiliation: Bucheon St Mary Hospital
name: Sungrae Kim, MD, Ph.D
role: STUDY_CHAIR
References: