louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00734448: Myo-inositol Administration in Gestational Diabetes
Official title: Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: gestational diabetes mellitus
carbohydrate intolerance
myo-inositol
insulin resistance
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Myo-Inositol is an insulin sensitizing agent that ameliorate the insulin resistance in women affected by gestational diabetes (GDM), but there is no information about the effect on the glucose profile. Maternal hyperglycemia of GDM, especially hypoglycemic excursions, are associated with adverse pregnancy outcome. Continuous Glucose Monitoring System (CGMS) is obviously better than intermittent self monitoring in detecting glucose profile and magnitude and duration of glucose fluctuations. For this reason, we propose a clinical trial to analyze the characteristics of glucose variability in GDM women,treated with diet and folic acid alone or with diet, folic acid and myo-inositol supplementation.

Detailed description: Our study is a randomized, prospective, controlled trial, including the first 30 consecutive Caucasian gestational diabetes patients diagnosed,according the International Association of Diabetes and Pregnancy Study Group (IADPSG) panel criteria, from November 2013 in the Department of Obstetric and Gynecology of Messina University (ITALY). After an informed consent they will be randomly assigned to receive (n. 15) diet and folic acid (400 mcg per day) alone or (n. 15) diet, folic acid (400 mcg per day) and myo-inositol (2 g. twice a day)supplementation. The insulin sensitivity index (HOMA-IR) and the glycemic profile will be monitor by CGMS for each patient at GDM diagnosis and after 8 weeks of treatment The pregnant women who will delivery before the time treatment (8 weeks) or who need insulin will be excluded.

Eligibility criteria: Inclusion Criteria:

* Gestational diabetes diagnosed within 28 weeks
* Caucasian pregnant women

Exclusion Criteria:

* Non Caucasian pregnant women
* Delivery before 8 weeks of treatment

Primary outcomes:
measure: Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile
timeFrame: Change from baseline in HOMA-IR at 8 weeks of treatment
Secondary outcomes:
measure: baby weight at delivery
timeFrame: After delivery
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina -
state: Sicilia
Study officials:
affiliation: University of Messina, ITALY
name: Rosario D'Anna, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03637348: Effect of TrueTear Corneal Surface Imaging
Official title: Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Myopia
Lead sponsor: Price Vision Group
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2018-08-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate the utility of TrueTear™ to improve anterior corneal surface imaging quality before cataract surgery, refractive lens exchange, or laser refractive surgery.

Detailed description: Corneal imaging will be repeated before and after TrueTear use during a single patient visit. Image quality measures will be compared.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery

Exclusion Criteria:

* A cardiac pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device (e.g. cochlear implant) in the head or neck
* Chronic or frequent nosebleeds, a bleeding disorder (e.g. hemophilia), or another condition that can lead to increased bleeding
* A known hypersensitivity (allergy) to the hydrogel material that comes into contact with the inside of the nose during use of the TrueTearTM device
* Pregnancy
* Presence of any ocular disease or condition which in the investigator's opinion would confound the study results

Primary outcomes:
measure: Surface Asymmetry Index (SAI) Assessed With Corneal Topography
timeFrame: Change from baseline SAI at 5-10 minutes after using the TrueTear device.
Secondary outcomes:
measure: Surface Regularity Index (SRI) Assessed With Corneal Topography
timeFrame: Change from baseline SRI at 5-10 minutes after using the TrueTear device.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
Study officials:
affiliation: Price Vision Group
name: Francis W Price, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652548: Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients
Official title: Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures
Keywords: Clavicle
Fracture
Ultrasound
Radiation
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2008-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children age 1-18 years presenting to a tertiary center pediatric emergency department complaining of recent traumatic shoulder injury.

Brief summary: This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.


Eligibility criteria: Inclusion Criteria:

* Age 1-18 years
* Pain from recent shoulder/clavicle injury
* Intact neurovascular exam
* Radiographs performed as part of normal ED evaluation

Exclusion Criteria:

* Hemodynamic instability
* Multisystem trauma
* Altered mental status
* Open wounds to injured shoulder
* Developmental delay
* Prior radiographs at another clinic/hospital for this injury
* Previous clavicle fracture on the affected side
* Ultrasound gel allergy
* Non-English-speaking parents/child (unable to give informed consent)

Primary outcomes:
measure: Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs
timeFrame: Single visit to emergency department
Secondary outcomes:
measure: Unblinded real-time bedside US by the ED physician vs. radiographs
timeFrame: Single ED visit
measure: Interoperator reliability between the blinded reviewer and bedside ED physician
timeFrame: Single ED visit
measure: FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs
timeFrame: Single ED visit
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Keith P Cross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05194748: Diaphragmatic Thickness and Pulmonary Function in Parkinson's Disease
Official title: Correlation of Diaphragmatic Thickness With Pulmonary Function in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease and Parkinsonism
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with Parkinson's Disease in our clinic between June 2021 and January 2023.

Brief summary: Ultrasound can give important information about the morphology of the diaphragm and the amount of contraction. Our aim, with the prediction that a restrictive pathology will occur in the pulmonary function with the addition of camptocormia in Parkinson's patients; to compare respiratory functions in Parkinson's patients with and without camptocormia, to investigate the correlation between ultrasonographically measured diaphragmatic thickness and pulmonary function test values.

Detailed description: Respiratory complications are one of the most common causes of death in Parkinson's patients. In Parkinson's disease, abnormal flexion of the thoracolumbar spine of 45° or more, which is called camptocormia, increases during walking or standing and disappears completely in the supine position. The prevalence of camptocormia among Parkinson's patients is about 7%. Camptocormia in Parkinson's disease is associated with significant disease disability, higher daily dopaminergic drug dosage, and cognitive impairment. Parkinson's patients with camptocormia often complain of shortness of breath, attributed to reduced pulmonary capacity due to limited chest expansion. Diaphragmatic dyskinesia in Parkinson's patients may also lead to a restrictive deterioration in respiratory functions.

Diaphragmatic thickness indicates diaphragmatic contraction and is correlated with PFT. Our aim; It is a comparison of respiratory functions in Parkinson's patients with and without camptocormia.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Parkinson's
* Volunteer to participate in the study

Exclusion Criteria:

* Being in contact with or suffering from COVID-19
* Having diseases that increase intra-abdominal pressure and venous insufficiency
* Having diseases that affect diaphragmatic motility
* Have had recent thoracic or abdominal surgery
* Having a parenchymal, pleural, or chest wall mass that may cause restriction on a recent chest X-ray or CT

Primary outcomes:
measure: Pulmonary function test
timeFrame: 1 hour
measure: Ultrasonography
timeFrame: 1 hour
Secondary outcomes:
measure: Camptocormia measurement
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University Faculty of Health Science
Study officials:
affiliation: Abant Izzet Baysal University
name: Ramazan Kurul, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04417348: Opsin Receptors in Melasma
Official title: Expression of Opsins Receptors in Melasma and Its Modification With UV-Visible Light Sunscreen and 0.05% Retinoic Acid.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
Collaborators: name: Hospital Central "Dr. Ignacio Morones Prieto"
First posted: 2020-06-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients with melasma divided in a UV-Visible light filter with 0.05% retinoic acid group and UV-Visible light filter alone
Primary purpose: BASIC_SCIENCE

Brief summary: Melasma is a hyperpigmentation disorder that is probably exacerbated by visible light. Opsin receptors (OPN 1, 2, 3, 4 y 5) were described in the skin, being capable of activating melanogenesis induced by visible light. The aim of this study was to evaluate the expression of OPN in melasma skin and its changes following treatment with UV-Vis filter and 0.05% retinoic acid for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with melasma, of 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had Melasma Activity and Severity Index (MASI) scores higher than 7

Exclusion Criteria:

* pregnancy or nursing, menopause, coexistence of other pigmentation conditions, heat exposure, regular exercise, diet restriction, consumption of food supplements or any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months, and women who had given birth within 1 year

Primary outcomes:
measure: MASI score
timeFrame: 3 months
Secondary outcomes:
measure: Opsin receptors
timeFrame: 3 months
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Study officials:
References:
citation: Regazzetti C, Sormani L, Debayle D, Bernerd F, Tulic MK, De Donatis GM, Chignon-Sicard B, Rocchi S, Passeron T. Melanocytes Sense Blue Light and Regulate Pigmentation through Opsin-3. J Invest Dermatol. 2018 Jan;138(1):171-178. doi: 10.1016/j.jid.2017.07.833. Epub 2017 Aug 24.
citation: Ozdeslik RN, Olinski LE, Trieu MM, Oprian DD, Oancea E. Human nonvisual opsin 3 regulates pigmentation of epidermal melanocytes through functional interaction with melanocortin 1 receptor. Proc Natl Acad Sci U S A. 2019 Jun 4;116(23):11508-11517. doi: 10.1073/pnas.1902825116. Epub 2019 May 16.
Clinical trial NCT00704548: Antihypertensive Effect of Simvastatin in Hypertensive Patients
Official title: Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2008-06-25
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile.

The purpose of this study is to determine the effect of Simvastatin on the blood pressure

Detailed description: This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.

Eligibility criteria: Inclusion Criteria:

* Hypertensive patients with controlled or uncontrolled blood pressure

Exclusion Criteria:

* Secondary causes of hypertension;
* Systolic Blood pressure \>= 180 mmHg and/or diastolic blood pressure \>= 110 mmHg
* Complain of side effects related to Statins
* Diabetes
* Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease)
* Renal disease (creatinine \> 1,5 mgdl).

Primary outcomes:
measure: Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM)
timeFrame: Eigth weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Miguel Gus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01227148: Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein Catabolism in Critically Ill Patients
Official title: Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critically Ill Patients
Keywords: critical care, glycemic control, insulin, nitrogen balance
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 112
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: To compare the differences of urinary nitrogen excretion, nitrogen balance and clinical outcomes between tightly insulin therapy and conventional insulin therapy in the ICU.

Detailed description: Critical illness is associated with increased circulating concentrations of proinflammatory cytokines, such as tumor necrosis factor (TNF-α), interleukin (IL)-1, and IL-6 which may be important mediators of insulin resistance and results in hyperglycemia. Altered glucose metabolism was caused by release of counter regulatory hormones such as glucagons; epinephrine and cortisol oppose the normal action of insulin, leading to an increase in skeletal muscle proteolysis. It did not know whether tightly glucose control had beneficial effect in urinary nitrogen excretion and nitrogen balance.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the adult ICU who had baseline blood glucose \> 180 mg/dl
* expected to require treatment in the ICU on 3 or more consecutive days.

Exclusion Criteria:

* pregnant patients
* patients with chronic renal loss (Chronic renal loss was defined as persistent acute renal failure, complete loss of kidney function \> 4 weeks)

Primary outcomes:
measure: 24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin.
timeFrame: up to the 14th study day
Secondary outcomes:
measure: ICU day, ventilator day, hospital day, episodes of acute renal injury, bacteremia, blood transfusion, gastrointestinal (GI) bleeding, hypoglycemia, and hospital mortality rate.
timeFrame: up to ICU discharge
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Chien-Wei Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu CW, Sun SF, Lin SL, Huang HH, Wong KF. Moderate glucose control results in less negative nitrogen balances in medical intensive care unit patients: a randomized, controlled study. Crit Care. 2012 Dec 12;16(2):R56. doi: 10.1186/cc11299.
Clinical trial NCT03587948: Shanghai Children and Adolescent Diabetes Eye Study
Official title: Shanghai Children and Adolescent Diabetes Eye Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Eye Diseases
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Fudan University
First posted: 2018-07-16
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2018 to 2028, children who are diagnosed with diabetes at the Children's Hospital of Fudan University in Shanghai, will be recruited as cases of diabetes. We will also recruit children without diabetes, who will be matched for age and gender, from this hospital as controls.

Brief summary: To compare the prevalence of eye disease between children and adolescents with diabetes mellitus and healthy people, and to analyze the related factors of eye diseases in diabetic patients.

Detailed description: A cohort study. From January 2018 to 2028, 300 cases of diabetic children in Children's Hospital of Fudan University in Shanghai will be selected as case group, and 300 healthy children without diabetes will be selected as the control group.

The purpose of the study is to guide and regulate eye health screening of children and adolescents with diabetes in Children's Hospital of Fudan University in Shanghai, build up the ranks with the general practitioner as the backbone combined, and provide comprehensive, continuous, and dynamic information service to diabetic eye disease health management. We expect to reduce the prevalence rate of diabetic eye disease, blindness and visual impairment of DR, and improve diabetics consciousness of eye health maintenance, thus upgrading the level of eye disease prevention and treatment in Shanghai.

Eligibility criteria: Inclusion Criteria:

* (1) provision of a written informed consent by a guardian;
* (2) age over 5 years and less than 18 years;
* (3) diagnosis of type 1 or type 2 diabetes based on the WHO diagnostic criteria for cases.

Exclusion Criteria:

* (1) eyelid diseases - eyelid entropion, eyelid ectropion, eyelid, ptosis, and palpebral dyskinesia;
* (2) conjunctival diseases - pterygium and conjunctivitis;
* (3) history of ocular surface chemical injury or use of eye drops with moisturizing artificial tears;
* (4) history of eye surgery within 6 months or history of retinal laser photocoagulation;
* (5) systemic diseases - Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave 's disease, systemic lupus erythematosus, and others.

Primary outcomes:
measure: Diabetic eye diseases
timeFrame: January 1, 2028
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention & Treatment Center
state: Shanghai
Study officials:
affiliation: Shanghai Eye Disease Prevention and Treatment Center
name: Haidong Zou, MD,PhD
role: STUDY_CHAIR
References: