louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02397525: An Open-Label Study to Evaluate Retreatment With LIPO-202
Official title: An Open-Label Study to Evaluate Retreatment With LIPO-202
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Central Abdominal Bulging
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2015-03-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.


Eligibility criteria: Inclusion Criteria:

* Provided consent
* Healthy male or non-pregnant female subjects
* BMI \< 30 kg/m2
* Stable diet and exercise routine
* Central abdominal bulging that is at least "Slight Bulge, Not Flat"

Exclusion Criteria:

* Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen
* Plan on starting a weight loss or exercise program during the study.
* Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
* Known hypersensitivity to study drugs
* Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202

Primary outcomes:
measure: Safety: vital signs, physical exams, laboratory tests
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: AboutSkin Dermatology
state: Colorado
city: Coral Gables
country: United States
facility: Dermatology Research Institute, LLC
state: Florida
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc
state: Georgia
city: New Orleans
country: United States
facility: Lupo Center for Aesthetic and General Dermatology
state: Louisiana
city: New York
country: United States
facility: Bass Plastic Surgery PLLC
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York
state: New York
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
Study officials:
affiliation: Neothetics, Inc
name: Maria Feldman
role: STUDY_DIRECTOR
References:
Clinical trial NCT04864925: Measurement of Viral Load Reduction in the Oral Cavity After a Regimental Use of OC Toothpaste Products
Official title: Measurement of Viral Load Reduction in the Oral Cavity After a Regimental Use of OC Toothpaste Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: SARS COVID 2 has caused a pandemic of proportions unparalleled in the past 100 years. The virus has an uncanny ability for transmission and as such has been difficult to control. The spread of the virus has affected everything from education, business, politics and survival. While the investigators have learned a great deal in the last 9 months they still face an uncertain day to day existence. Health care workers are particularly vulnerable to transmission of this virus because of their close contact with patients. Moreover, dentists are particularly vulnerable because the virus is spread via aerosols which are generated quite easily in the dental office putting dentists and their associates at risk. The oral cavity appears to be a likely domain for viral carriage particularly since both taste and smell are hallmark effects of the virus. With these issues at hand it will be of great advantage to have a simple routine oral hygiene method in the effort to reduce the oral viral load. There is some reason to expect that oral hygiene procedures with known anti-microbial effects could have some use in our efforts to reduce or control the oral viral load. With this issue in mind investigators feel that stannous fluoride could modify the virus in such a manner as to effectively reduce the oral viral load.

Detailed description: Study will measure reduction of SARS-CoV-2 levels in the oral cavity after brushing for up to an hour. Subject sampling will occur at baseline, 15 min, 30 min, and 60 min

Eligibility criteria: Inclusion Criteria:

* Enrolled subjects between the ages of 18-64 and have tested positive for Covid19.

Exclusion Criteria:

-

Primary outcomes:
measure: Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR
timeFrame: Baseline
measure: Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR
timeFrame: 30 minutes after brushing
measure: Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR
timeFrame: 60 minutes after brushing
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers University Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT01219725: Cardiovascular Prophylaxis for Postmenopausal Women
Official title: Can a Moderate Intensity Exercise Training Programme Improve Cardiac Function and Known Cardiovascular Risk Factors in Middle-aged Women?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cardiovascular Disease
Keywords: Body composition
Endothelial function
Lipoprotein profile
Inflammatory markers
Aerobic capacity
Thrombotic markers
Arterial stiffness
Cardiac function
Traditional and emerging cardiovascular disease risk factors
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to examine the effect of 6 months moderate intensity exercise training completed three times per week upon traditional and emerging cardiovascular disease risk factors in postmenopausal women both with and without type 2 diabetes. These risk factors include blood markers associated with increased risk such as cholesterol, insulin, glucose and markers of inflammation plus measures of body fat, heart and lung fitness, vascular stiffness and vascular function. The study hypothesised that moderate intensity exercise training would intervene in the exaggerated risk seen in women following the menopause, especially in those with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Healthy and stable type II diabetic postmenopausal women (cessation of menstrual periods for 12 months and confirmed with LH/FSH samples) aged 45 - 65 years old for the cross sectional analysis and exercise training study.

Exclusion Criteria:

* Identified abnormalities during baseline testing.
* Vigorously active women.
* Women who are pregnant.
* Women with serious systemic or psychological disorders (e.g. COPD, asthma, clinical depression).
* Women with known coronary artery disease.
* Women with significant cardiovascular pathologies and associated medication.
* Women with type 1 or insulin treated diabetes.
* Women with diabetes with complications.
* Women with unstable diabetes or hypertension.
* Women with any cancer.
* Women with musculoskeletal impairments or contraindications to exercise.

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: 6 months
Secondary outcomes:
measure: lipoprotein profile
timeFrame: 6 months
measure: Flow mediated dilation
timeFrame: 6 months
measure: Cardiac power output
timeFrame: 6 months
measure: Arterial stiffness
timeFrame: 6 months
measure: Inflammatory markers
timeFrame: 6 months
measure: Body composition
timeFrame: 6 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Centre for Sports and Exercise Sciences, University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Karen M Birch, BSC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03330925: Safety and Feasibility of the ElastiMed's SACS
Official title: Safety and Feasibility of the ElastiMed's SACS - Smart Active Compression Stocking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compression; Vein
Lead sponsor: ElastiMed ltd
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The main objective of this study is to demonstrate the safety and the feasibility of this device, and its ability to increase venous blood flow

Primary safety Endpoint:

To demonstrate the safety of the device- no serious adverse effect

Primary feasibility Endpoint:

Increase the blood flow velocity

The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and the femoral vein.

The volunteers will rest at controlled environment room . Measurements will be performed after 30 min of rest without the device on the leg (baseline) and after 30 min of device activity .


Eligibility criteria: Inclusion Criteria:

1. Adults 18\<x\<70 Years
2. Written informed consent has been sign by subject
3. With two healthy limbs - Normal blood flow according to leg deep vein Duplex test

Exclusion Criteria:

1. Positive pregnancy test
2. Breastfeeding woman
3. BMI 18.5 \> X or X\>25
4. Suffering from edema
5. Atrial fibrillation
6. DVT
7. Ulcers or cellulitis in regions covered by the compression device
8. Active phlebitis
9. Muscular disorders, or compartment syndrome
10. Heavy smoker \>10 cigarettes a day
11. Subjects with altered mental status/inability to provide informed consent
12. Hematological disorders

Primary outcomes:
measure: Safety measured by the number of subjects with serious adverse events
timeFrame: 60 min
measure: Device feasibility measured by an increase in blood flow velocity
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Vascular Surgery Department, HILLEL YAFFE Medical Center,
Study officials:
affiliation: ElastiMed ltd
name: Vered Shuster, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03083925: Viatorr CX Case-control Study for Complications of Portal Hypertension
Official title: Viatorr Control Expansion Compared to Bare-metal and Regular Viatorr for Complications of Portal Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhoses
Portal Hypertension
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case-control study using the patients in our center receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents (all available data from our center). Thereby, we will choose 20 patients receiving Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year. The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS. We will investigate a total 125 patients with the primary composite-endpoint HE/readmission, and secondary endpoints will be liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.

Brief summary: To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12 months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4 months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE, readmission, liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.

Detailed description: Case-control study using the patients in the University Clinic Bonn receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents.

Of these patients, 20 patients will receive Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year.

The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS.

A total of 125 patients with the primary composite-endpoint HE/readmission will be investigated Secondary endpoints are liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.

Eligibility criteria: Inclusion Criteria:

* Patients suitable for TIPS

Exclusion Criteria:

* Contraindication for TIPS

Primary outcomes:
measure: Readmissions
timeFrame: 12 months
Secondary outcomes:
measure: Hepatic encephalopathy (HE)
timeFrame: 12 months
measure: Liver injury
timeFrame: 12 months
measure: Response to TIPS
timeFrame: 12 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Laboratory for Liver Fibrosis and Portal Hypertension
Study officials:
affiliation: Laboratory for Liver Fibrosis and Portal Hypertension
name: Jonel Trebicka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04740125: SURVEY ABOUT STRESS-COVID IN HEALTH CARE WORKERS IN NORTH AFRICA COUNTRY
Official title: PSYCHOLOGICAL IMPACT, STRESS FACTORS AND BEHAVIOURS IN HEALTH CARE PROFESSIONALS DURING THE COVID-19 PANDEMIC IN TUNISIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HEALTH CARE WORKERS
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
First posted: 2021-02-05
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HEALTH CARE WORKERS all

Brief summary: This study aimed to investigate the psychological impact of the COVID-19 outbreak on healthcare workers (HCWs) and to identify ways of coping with this unprecedented stressful situation.

Detailed description: This was a cross-sectional study based on an online questionnaire that included 62 questions (scores, 0 - 3). The chi-square (χ²) test was used to compare the responses between professional groups, age groups, and genders.

Eligibility criteria: Inclusion Criteria:

* HEALTH CARE WORKERS

Exclusion Criteria:

* no one

Primary outcomes:
measure: STRESS-COVID
timeFrame: 01 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hospital of Tunis
state: Montfleury
Study officials:
affiliation: General Administration of Military Health, Tunisia
name: Hedi Gharsallah, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02744625: Physiologic Study of Cerebral Perfusion
Official title: Physiologic Study of Cerebral Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Perfusion Pressure
Vasopressor Agents
Shock
Magnetic Resonance Imaging (MRI), Functional
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with and without sedation) and in vasopressor-dependent patients


Eligibility criteria: Healthy Subjects :

* Inclusion criteria :

  * being over 18 years old
* Exclusion criterias :

  * having a positive serum pregnancy test
  * having a contraindication to MRI
  * having a contraindication to receive light sedation with propofol
  * suffering of claustrophobia or of anxiety disorder

Shock Subjects :

* Inclusion criterias :

  * being over 18 years old
  * being hospitalized to the medical intensive care unit of the CHUS Fleurimont
  * being in a stabilized shock state, primarily of distributive etiology
  * having received an appropriate fluid resuscitation, as judged by the attending physician
* Exclusion criterias :

  * having a different primary etiology of shock than distributive (cardiogenic, hypovolemic, obstructive)
  * needing vasopressor therapy as the result of extracorporeal circulation
  * having known cerebral lesions
  * having an intra-aortic balloon pump
  * being in a palliative or near end-of-life situation
  * having a contraindication to MRI
  * suffering of claustrophobia or of anxiety disorder

Primary outcomes:
measure: Global and regional cerebral blood flow
timeFrame: Within 15 minutes of intervention initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: François Lamontagne
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06800625: Manual Versus Sonic-powered Toothbrushing for Plaque Reduction in Patients with Peri-implant Mucositis
Official title: Manual Versus Sonic-powered Toothbrushing for Plaque Reduction in Patients with Peri-implant Mucositis: Randomized Controlled Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Toothbrushing
Periimplant Diseases
Keywords: Biofilm
Dental İmplant
Peri-implant mucositis
Toothbrushing
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Niğde Ömer Halisdemir University
First posted: 2025-01-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who applied to Niğde Ömer Halisdemir University Faculty of Dentistry Periodontics Clinic between 15.04.2023 and 15.06.2023 for the control of dental implants and/or periodontal treatment, volunteered to participate in the study and met the following criteria were included in the study. Written consent was obtained from volunteer patients for the research.

Brief summary: Aim: To compare the effect of manual and sonic-powered toothbrushing on biofilm control in patients with peri-implant mucositis.

Materials and methods: The study was completed with a total of 41 patients, 21 in the sonic tooth brushing group and 20 in the manual tooth brushing group. The patients' baseline, 3rd-month, 6th-month and 9th-month periodontal examination data (Modified Gingival İndex (MGI), Modified plaque index (MPI), Bleeding on the probing index (BOP), Pocket depth (PD), Gingival Recession (GR) and Gingival Biotype (GB)) were analyzed.


Eligibility criteria: Inclusion Criteria:

1. Bleeding on probing around the implant
2. No bone loss around the implant in the radiograph
3. Having adequate keratinized gingiva around the implant
4. The presence of an implant prosthesis that was installed at least three months previously
5. No systemic disease
6. no smoke
7. No use of antibiotic medications within the previous three months

Exclusion Criteria:

1. Patients with missing data and who do not allow data use
2. Smoker
3. Data from pregnant and lactating patients
4. Pocket depth around the implant is ≥ 5
5. Patients with peri-implantitis (bone loss around the implant)
6. Patients with insufficient attached gingiva around the implant

Primary outcomes:
measure: Modified Gingival İndex (MGI)
timeFrame: baseline, 3rd-month, 6th-month and 9th-month
measure: Modified plaque index (MPI)
timeFrame: baseline, 3rd-month, 6th-month and 9th-month
Secondary outcomes:
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University, Dentistry Faculty, Periodontology Department
Study officials:
References:
Clinical trial NCT00608725: Pathophysiology of Orthostatic Intolerance
Official title: Pathophysiology of Orthostatic Intolerance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tachycardia
Postural Orthostatic Tachycardia Syndrome
Keywords: heart rate
blood pressure
blood volume
sympathetic nervous system
orthostatic tachycardia
orthostatic intolerance
POTS
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-02-06
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to describe the mechanism of orthostatic intolerance, relying on cardiovascular physiological studies. The syndrome is of undetermined etiology, but the syndrome causes impairment of a number of young adults, females more than males, with symptoms of tachycardia, fatigue, lightheadedness, palpitations, blurred vision, chest discomfort, difficulty concentrating, and dizziness with the upright posture. It is believed that many different pathophysiological processes can give rise to this disorder.


Eligibility criteria: Inclusion Criteria:

* Orthostatic intolerance

Exclusion Criteria:

* Inability or unwillingness to give informed consent

Primary outcomes:
measure: Physiological abnormalities in orthostatic intolerance
timeFrame: 1 day
Secondary outcomes:
measure: blood volume
timeFrame: 1 day
measure: intrinsic heart rate
timeFrame: 1 hour
measure: quantitative sweat testing
timeFrame: 2 hours
measure: residual sympathetic function after pharmacological autonomic blockade
timeFrame: 3 hours
measure: norepinephrine spillover
timeFrame: 3 hours
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: David Robertson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mustafa HI, Garland EM, Biaggioni I, Black BK, Dupont WD, Robertson D, Raj SR. Abnormalities of angiotensin regulation in postural tachycardia syndrome. Heart Rhythm. 2011 Mar;8(3):422-8. doi: 10.1016/j.hrthm.2010.11.009. Epub 2011 Jan 22.