louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03438266: A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
Official title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Volume Deficit in the Mid-face
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 66
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.


Eligibility criteria: Inclusion Criteria:

Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);

Exclusion criteria:

* Has any facial procedures or trauma that may interfere with the study procedures and results;
* Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;
* Has active autoimmune disease;
* Has current cutaneous or mucosal inflammatory or infectious processes.

Primary outcomes:
measure: Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score
timeFrame: Baseline (Screening) to Month 1
Secondary outcomes:
measure: Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score
timeFrame: Baseline (Screening) to Month 1
measure: Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score
timeFrame: Baseline (Screening) to Month 1
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Hackensack
country: United States
facility: Skin Laser & Surgery Specialists of NY/NJ
state: New Jersey
city: White Plains
country: United States
facility: Rhoda S. Narins, MD, PC
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions, PA
state: North Carolina
Study officials:
affiliation: Allergan
name: Steve Abrams
role: STUDY_DIRECTOR
References:
Clinical trial NCT02858466: Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity
Official title: Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).

This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain.

It induces a loss of sensitivity and likely reorganization of brain activity that are causing pain and which are the subject of this study.

Previous studies in functional neuroimaging has focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally. The authors failed to assess the part of the effect of the loss of sensory afferents (deafferentation) and the basal brain function.

Indeed, the operation without any sensory stimulation is not known yet is the initial level of activity which is the benchmark for studying brain function during stimulation. The objective of this study is to understand what are the cortical systems of allodynic dysfunctional in patients compared with controls at baseline.


Eligibility criteria: Inclusion Criteria for patients :

* major
* with nervous pain : chronic or peripheric
* treatment not stable opioid since one week
* signed consent

Inclusion Criteria for witnesses :

* major
* without chronic pain
* signed consent

Exclusion Criteria for 2 groups :

* severe psychiatric history
* presence of an active nervous lesion
* subject with morphine treatment
* contraindication to MRI scan

Primary outcomes:
measure: cerebral blood flow
timeFrame: at baseline
Secondary outcomes:
measure: rate of grey matter
timeFrame: at baseline
measure: structure of the networks
timeFrame: at baseline
measure: connection of the networks
timeFrame: at baseline
measure: cortical loss
timeFrame: at baseline
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Roland PEYRON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02775266: Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes
Official title: Effect of Systemic Administration of ALA (Alpha Lipoic Acid) as an Adjunct to Scaling and Rootplaning on Serum Resistin Levels in Patients With Chronic Periodontitis and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Periodontitis
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the effectiveness of non surgical periodontal therapy in addition to antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease

Detailed description: A total of 40 patients with diabetes and chronic periodontitis attending the department of periodontics will be recruited in the study. 40 subjects will be randomly divided into two groups(control group and test group with 20 subjects in each group). Clinical parameters such as gingival index, periodontal index, random blood sugar levels(RBS) and glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and 2ml of blood sample will be collected by venepuncture ( baseline and after 3 months) and stored in Ethylenediaminetetraacetic acid containing vials to identify the levels of resistin in the patients by Enzyme linked immunosorbent assay. Group A will receive Alpha lipoic acid at baseline for a period of 3 months. Both the groups will receive scaling and rootplaning at baseline.

Eligibility criteria: Inclusion Criteria: Diabetic patients with Chronic periodontitis.

-

Exclusion Criteria: Smokers, Pregnant \& lactating women, Prior periodontal therapy within 3 months.

Primary outcomes:
measure: Serum Resistin Levels and HBAIC Levels
timeFrame: 3 months
Secondary outcomes:
measure: Gingival Index
timeFrame: 3 months
measure: Probing pocket depth
timeFrame: 3 months
measure: Clinical Attachment levels
timeFrame: 3 Months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Mohans Diabetic Centre
state: Telangana
Study officials:
affiliation: PANINEEYA INSTITUTE OF DENTAL SCIENCES ROAD NO: 5, KAMALANAGAR DILSUKHNAGAR, HYDERABAD - 500060
name: Kinnera Surapaneni, [MDS]
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor&HOD Dept.of.Periodontics,PMVIDS
name: Rekha R Koduganti, MDS Perio
role: STUDY_DIRECTOR
References:
citation: Mealey BL, Oates TW; American Academy of Periodontology. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. doi: 10.1902/jop.2006.050459.
citation: Pendyala G, Thomas B, Kumari S. The challenge of antioxidants to free radicals in periodontitis. J Indian Soc Periodontol. 2008 Sep;12(3):79-83. doi: 10.4103/0972-124X.44100.
Clinical trial NCT04259866: FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS
Official title: FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS: An Analysis of Findings Leading to Recall and Work-up in ASL Avellino Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Screening
Lead sponsor: "G Criscuoli" Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 4500
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female population candidated to breast cancer screening program

Brief summary: To analyse false positives in breast cancer screening with tomosynthesis versus 2D mammography. The Avellino Breast Tomosynthesis Screening Trial is a observational population-based study that analyze souspicious findings in tomosynthesis slice images.

This study is based on two years screening and tomosynthesis was analzyed by two expert breast radiologists.


Eligibility criteria: Inclusion Criteria:

* breast cancer screening population

Exclusion Criteria:

* previous cancer
* breast prostheses

Primary outcomes:
measure: recall rate
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: Graziella Di Grezia
state: Av
Study officials:
References:
Clinical trial NCT00692666: Letigen® and Cardiovascular Morbidity
Official title: Letigen® and Cardiovascular Morbidity. A Register-Based Epidemiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Myocardial Infarctions
Sudden Death
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Nycomed Group, Langebjerg 1, 4000 Roskilde, Denmark
First posted: 2008-06-06
Enrollment: 300000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: Letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic and appetite-inhibiting properties. The drug was used as adjuvant treatment of obesity from 1990 and up to 2002 when it was withdrawn from the market by the manufacturer. The basis for this was a number of spontaneous reports about patients that died during treatment with Letigen®.

The causal relation has never been addressed. There are only sparse data from randomised studies and the above-mentioned reports are not conclusive.

We propose a controlled study based on data from Statistics Denmark that hold a complete copy of the Prescription Register of the Danish Medicines Agency and the Danish Hospital Discharge Register. The aim of the study would be to determine whether there is an excess frequency of deaths and serious cardiovascular events that can not be explained by particular characteristics of users of the drug. A well-known problem in such observational studies is a fundamental incomparability between users and non-users of drugs. In the present setting, it should be expected that use of Letigen® is associated with high BMI, smoking, alcohol abuse, type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy lifestyle. Thus, an uncritical comparison between users and non-users of Letigen® regarding serious cardiovascular events will probably show an excess frequency that can not necessarily be attributed to the drug. This problem can be addressed by a special epidemiological technique - the case-crossover design - which is particularly robust to such comparability problems. In brief, only cases should be included. Controls are the same persons at an earlier time, , where the case-defining disease has not yet developed. The exposure of cases will be compared with the exposure of the same persons' case history.

To account for the effect of chronic exposure, we also perform, as a secondary analysis, a conventional case-control study nested within the cohort of Letigen users, and employing a risk-set sampling technique.


Eligibility criteria: Inclusion Criteria:

* Use of letigen TM within the period Jan 1995 - Dec 2001
* The occurrence of a case-defining event

Exclusion Criteria:

* A cancer diagnosis other than non-melanoma skin cancer
* Age outside the range 18-70

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern Denmark
name: Jesper Hallas, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519466: Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
Official title: Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Diabetes
SMBG
Insulin calculator
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
* HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
* Age 18 and over
* In the investigator's opinion, thought technically capable of using masked CGM
* Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
* Willing to perform a minimum of 4 SMBG tests per day during study

Exclusion Criteria:

* Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
* Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
* Subject is pregnant / planning to become pregnant within the planned study timeline
* Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
* Subject is currently on an insulin pump
* Subject is currently using the FreeStyle InsuLinx
* Subject is currently using the FreeStyle Freedom Lite
* Subject is currently using CGM
* Subject has an allergy to medical grade adhesives

Primary outcomes:
measure: Time in Target Blood Glucose Range
timeFrame: Day 1-15 compared with Day 60-74
Secondary outcomes:
measure: HbA1c
timeFrame: Day 1 compared with Day 74
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.
timeFrame: Day 60 compared to day 1
Other outcomes:
Locations:
city: Bad Mergentheim
country: Germany
facility: Diabetes Zentrum Mergentheim
city: Hannover
country: Germany
facility: Diabetes-Zentrum für Kinder und Jugendliche
city: Ulm
country: Germany
facility: Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm
city: Amsterdam
country: Netherlands
facility: VU University Medical Centre (VUMC)
Study officials:
affiliation: VU University Medical Centre (VUMC)
name: Prof. Michaela Diamant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486626: Endometrial Thickness and Subendometrial Vascularity in Anovulatory Polycystic Ovarian Syndrome Patients Treated by Metformin
Official title: Endometrial Thickness And Subendometrial Vascularity In Anovulatory Polycystic Ovarian Syndrome Patients Treated by Metformin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Anovulatory
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 85
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The participants will receive metformin 500mg 3times per day for 3months and one month is left for spontaneous pregnancy to occur or not (primary outcome ) and the investigators will check endometrial thickness and subendometerial vascularity as markers of endometrial receptivity before and after the treatment.


Eligibility criteria: Inclusion Criteria:

* PCO syndrome patients have the following criteria:

Age of the patient between 20 - 40 years old. All subjects are not on a specific diet nor a certain program of physical exercise Complaining of infertility either primary or secondary due to PCOS.

N.B: The diagnosis of PCO syndrome was made according to the Androgen Excess and Polycystic Ovarian Syndrome Society: the presence of the following criteria have been required for the diagnosis of PCO syndrome:

Hyperandrogenism: Hirsutism and/or Hyperandrogenaemia Ovarian Dysfunction : Oligo-Anovulation and /or Polycystic ovaries Exclusion of other Androgen Excess or related disorders as :( deficient nonclassic adrenal hyperplasia, androgen-secreting neoplasms, androgenic/anabolic drug use or abuse, Cushing's syndrome, the Hyperandrogenic-Insulin Resistance-Acanthosis Nigricans syndrome, thyroid dysfunction, and hyperprolactinemia).

Exclusion Criteria:

* Age below 20 or above 40. Women who intended to start a diet or a specific program of physical activity. Concurrent medical illness as cardiovascular, neoplastic and hepatic disorder. Pelvic pathology. Tubal, Uterine, Male factor of infertility. Endocrinological factors including: diabetes Mellitus,hypothyroidism, hyperprolactinaemia, Cushing's syndrome, and non- classical congenital adrenal hyperplasia.

Patients who are ovulatory during the ovarian cycle

Primary outcomes:
measure: pregnancy
timeFrame: 4 months
Secondary outcomes:
measure: Endometrial thickness and Sub Endometrial vascularity
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University Maternity Hospital
name: Waleed Khalaf, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05106426: Healthy Caregivers-Healthy Children
Official title: Healthy Caregivers-Healthy Children Phase 3: Children With Special Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Child, Only
Keywords: obesity prevention
childhood
special needs
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2021-11-03
Enrollment: 348
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to further develop and examine the Health Caregivers Healthy Children (HC2) program, which encourages obesity prevention through promoting healthy eating and physical activity.


Eligibility criteria: Center Inclusion Criteria:

1. have \>30 children ages 2-to-5 with a with or at-risk for a disability or special healthcare need
2. Serve low income families
3. Reflect the ethnic diversity of the Miami Dade county Public School System (60% Hispanic, 20% non-Hispanic Black, 20% Non Hispanic White).

Child inclusion criteria:

1. Children with an Individual Education Plan or at-risk based on social and economic variables
2. child ages 2-5
3. child enrolled in a childcare center

Exclusion Criteria:

1) Children with feeding tubes or those that bring their own meals due to dietary restrictions

Primary outcomes:
measure: Change in Body Mass Index Percentile
timeFrame: Baseline, Up to 3 years
measure: Change in Environment and Policy Assessment and Observation tool) and the Healthy Environment Rating Scale
timeFrame: Baseline, Up to 3 years
Secondary outcomes:
measure: Change in Healthy Caregivers-Healthy Children (HC2) Survey
timeFrame: Baseline, Up to 3 years
measure: Change in Health Environment Rating Scale
timeFrame: Baseline, Up to 3 years
measure: Change in Parent Stress Index
timeFrame: Baseline, Up to 3 years
measure: Change in Childcare Worker Job Stress Index
timeFrame: Baseline, Up to 3 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Ruby Natale
role: PRINCIPAL_INVESTIGATOR
References: