louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01607515: Non Invasive Measurement of Cardiac Index by Impedance Cardiography
Official title: Non Invasive Measurement of Cardiac Index by Impedance Cardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension
Cardiac index
impedance cardiography
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg in the right heart catheterization.

There are different forms of PH defined in the classification of Dana Point 2008.

PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like echocardiography, stress echocardiography and cardio pulmonary exercise testing.

For prognosis of PH patients the limitation of the pulmonary circulation is very important. Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The gold standard for CI measures is the thermodilution, an invasive method performed during right heart catheterization.

Detailed description: In this study the investigators want to evaluate the impedance cardiography (ICG) as a non invasive method for CI measurement. An alternating current of max 400µA and 45 kHz is conducted through the body. The way of the smallest resistance is the blood in the aorta. The impedance changes with the pulsatile blood flow. Out of the Impedance change there can be calculated the CI.

Eligibility criteria: Inclusion Criteria:

* patients who have right heart catheterization written informed consent

Exclusion Criteria:

* patients who don't have right heart catheterization no written informed consent

Primary outcomes:
measure: Comparison of CI measured by ICG and Thermodilution
timeFrame: recruitment over 1.5 year (Data collection), followed by data analysis and interpretation (overall 2 yearsfrom start of recruitment)
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05759715: Iris Color and Day-Night Changes in the Sympathovagal Ratio
Official title: Iris Color and Day-Night Changes in the Sympathovagal Ratio
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iris Diseases
Keywords: LF/HF ratio, iris color, melanin
Lead sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-08
Enrollment: 621
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 650 healthy individuals between the ages of 16 and 50 who applied for cardiac examination and had normal findings were recruited for the study.

Brief summary: Iris melanocytes are innervated by parasympathetic and sympathetic nerve endings. Light affects autonomic nervous system activity via the retino-hypothalamic pathway. The hypothesis that the day-to-night variations in the sympatovagal ratio (LF/HF) may differ among individuals with different brown iris patterns was tested.

Detailed description: A total of 621 healthy adults, aged between 16 and 50, with brown eyes and not diagnosed with a disease that might affect the autonomous nerve system were included in the study. A digital camera was used to acquire iris photos. Subjects were grouped into iris color groups (2-0 bg, 1-0 bg, 1-1 db, 1-1 lb, 2-0 b, and 1-0 b). Iris photos were analyzed with Picture Color Analyzer RBG software. The Central/Peripheral (R/RGB) ratio was used for objective distinction between the groups. Using 24-h Holter ECG monitoring, the change in the sympathovagal ratio from day (between 07:00 and 23:00 hrs) to night (between 23:00 and 07:00 hrs) was determined with the formula \[(Day - Night) LF/HF)/Day LF/HF\].

Eligibility criteria: Inclusion Criteria:

A total of 650 healthy individuals between the ages of 16 and 50 .

Exclusion Criteria:

Diseases that could affect the autonomic nervous system; Obesity Obstructive sleep apnea syndrome Hypertension Diabetes mellitus Atrial fibrillation Coronary disease Heart failure Goiter, etc.

Primary outcomes:
measure: LF/HF ratio
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00567515: Safety and Effectiveness of Left Atrial Appendage Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.


Eligibility criteria: Inclusion Criteria:

1. Documented history (paroxysmal, persistent or permanent) of AF \[one episode within the last 12 months of enrollment\]
2. Elective Maze procedure
3. Suitable anatomy
4. Able and willing to sign informed consent
5. Age over 18 years

Exclusion Criteria:

1. Patient from Intensive Care Unit with either:

   1. intra-venous catecholamines
   2. ventilator
   3. cardiac index \<1.8 l/min.
2. Reoperative Cardiac Surgery
3. Systemic or Inflammatory disease
4. Dialysis
5. Recent myocardial infarction (\< 21 days)
6. History of pericarditis
7. Patient taking part in any other device or drug study
8. Patient with known sensitivity or allergy to any of the device components
9. Pregnancy

Primary outcomes:
measure: Safety - Device related complications
timeFrame: 30 days
measure: Efficacy - Occlusion of the LAA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Michele Genoni, MD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caliskan E, Sahin A, Yilmaz M, Seifert B, Hinzpeter R, Alkadhi H, Cox JL, Holubec T, Reser D, Falk V, Grunenfelder J, Genoni M, Maisano F, Salzberg SP, Emmert MY. Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery. Europace. 2018 Jul 1;20(7):e105-e114. doi: 10.1093/europace/eux211.
citation: Emmert MY, Puippe G, Baumuller S, Alkadhi H, Landmesser U, Plass A, Bettex D, Scherman J, Grunenfelder J, Genoni M, Falk V, Salzberg SP. Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial. Eur J Cardiothorac Surg. 2014 Jan;45(1):126-31. doi: 10.1093/ejcts/ezt204. Epub 2013 May 8.
citation: Salzberg SP, Plass A, Emmert MY, Desbiolles L, Alkadhi H, Grunenfelder J, Genoni M. Left atrial appendage clip occlusion: early clinical results. J Thorac Cardiovasc Surg. 2010 May;139(5):1269-74. doi: 10.1016/j.jtcvs.2009.06.033. Epub 2009 Nov 1.
Clinical trial NCT01762215: Policy on Optimal Epilepsy Management
Official title: Policy on Optimized Epilepsy Management: The Use of an Online Social Media Platform to Collect Patient-Entered Data in the Veteran Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Seizure Disorder
Keywords: Epilepsy
Seizure
Veteran
Lead sponsor: Northern California Institute of Research and Education
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
name: Veterans Administration Epilepsy Centers of Excellence (ECoE)
name: University of California, San Francisco
name: PatientsLikeMe
name: UCB Pharma
First posted: 2013-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study examines the use of an online social media platform (PatientsLikeMe) to assist Veterans with epilepsy. The hypothesis is that the online social media platform, PatientsLikeMe, will improve selected patient-reported outcomes on perceived self-management skills for patients who engage in the website functions.


Eligibility criteria: Inclusion Criteria:

* US Veteran
* Epilepsy (Seizure Disorder)
* \>18 years

Exclusion Criteria:

-

Primary outcomes:
measure: Epilepsy Self-Management
timeFrame: 6 weeks
measure: Epilepsy Self-Efficacy
timeFrame: 6 weeks
Secondary outcomes:
measure: Epilepsy Self-Management Information Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
References:
Clinical trial NCT01858415: Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles
Official title: Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Wrinkles
Lead sponsor: Pollogen
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.

Detailed description: The TriPollar technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.

Eligibility criteria: Inclusion Criteria:

* Subject read, discussed and signed the Consent Form,
* Healthy female/male aged 35 65 years,
* Has facial wrinkles,
* Capable of reading, understanding and following instructions of the procedure to be applied,
* Able and willing to comply with the treatment and follow-up schedule.

Exclusion Criteria:

* Listed in approved protocol, and ICF

Primary outcomes:
measure: Safety of TriPollar
timeFrame: 6 months
measure: Efficacy of TriPollar
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Ronald L Moy, Inc.
state: California
city: Plano
country: United States
facility: Reaserch Across America
state: Texas
Study officials:
affiliation: Pollogen
name: Mira Barki, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06117215: Prevalence of Premenstrual Syndrome in Women of Reproductive Age
Official title: Prevalence of Premenstrual Syndrome in Women of Reproductive Age
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premenstrual Syndrome
Keywords: Premenstrual syndrome
women reproductive age
prevalence
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women of chilbearing age

Brief summary: The menstrual cycle is a recurring process in the lives of women from puberty until menopause. This cycle can cause various discomforts, including premenstrual syndrome.

Described differently, premenstrual syndrome is a collection of physical and psychological symptoms that occur during the luteal phase of the menstrual cycle and subside upon the arrival of menstruation. This definition is conditioned by the existence of a free interval of at least one week between the end of the period and the appearance of these symptoms, as well as a global impairment of functioning and quality of life for women.

The impact on the personal, social, and professional lives of affected women, as well as the pain and discomfort it causes, may be perceived as insignificant or normal by women. Therefore, few women report the existence of these disorders to healthcare professionals. As the subject is not approached, these women are not taken care of even though therapeutic solutions could be proposed.

This pathology affects a large number of women, but its prevalence differs greatly depending on the studies conducted on the subject, suggesting a lack of knowledge of this syndrome.

Detailed description: The main aim is to describe the prevalence of premenstrual syndrome among women of reproductive age.

Eligibility criteria: Inclusion Criteria:

* women in childbearing age, i.e., menstrual or secondary amenorrhoea, non-menopausal
* Over 18 years of age
* Agreeing to participate in the study

Exclusion Criteria:

* Menopause
* Having had a hysterectomy
* With primary amenorrhea
* Protected by law
* Refusing to participate in the study

Primary outcomes:
measure: premenstrual syndrome
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Ufr Medecine Urca
Study officials:
affiliation: CH Épernay
name: Kristner Pauline, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04156815: Treatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy
Official title: Treatment of Acne Vulgaris Using 1,565 nm Non-ablative Fractional Laser in Combination With Isotretinoin and Pricking Blood Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Acne scars
1,565 nm non-ablative fractional laser
Isotretinoin
pricking blood therapy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: BACKGROUND Isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (AV) but its side effect is a major concern for Asian patients.

OBJECTIVE Investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (NAFL) in combination with isotretinoin and pricking blood therapy (PBT) for treatment of AV.

METHODS A retrospective analysis of 60 patients with moderate-to-severe AV was performed. Four groups (n=15) were evaluated: 1,565nm NAFL alone, oral isotretinoin alone, double therapy (NAFL + isotretinoin) and triple therapy (NAFL + isotretinoin + PBT).

Detailed description: BACKGROUND Isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (AV) but its side effect is a major concern for Asian patients.

OBJECTIVE Investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (NAFL) in combination with isotretinoin and pricking blood therapy (PBT) for treatment of AV.

METHODS A retrospective analysis of 60 patients with moderate-to-severe AV was performed. Four groups (n=15) were evaluated: 1,565nm NAFL alone, oral isotretinoin alone, double therapy (1,565 nm non-ablative fractional laser + isotretinoin) and triple therapy (1,565 nm non-ablative fractional laser+ isotretinoin + PBT).

Eligibility criteria: Inclusion Criteria:

* Patients ranged in age from twenty to forty years old
* Clinically diagnosed as a facial acne patient
* The patients meet the needs of the research program of this topic

Exclusion Criteria:

* pregnancy
* liver or kidney functional abnormality
* skin ulceration with active bacteria
* fungal or viral infection or skin cancer
* coagulation disorders
* patients on drugs of agents
* systemic diseases such as cardiovascular disease
* epilepsy
* diabetes
* immunodeficiency disease
* active psoriasis

Primary outcomes:
measure: Visia CR imaging system
timeFrame: change from week0 to week24
measure: Antera3D® system
timeFrame: change from week0 to week24
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Dermatology Derpartment of Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Gang Wang, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02072915: EUS-FNA With and Without Suction
Official title: Randomized Single Blind Controlled Trial of EUS-FNA With and Without Suction for Adequate Cellblock Sample Procurement of Solid Pancreatic Mass Lesions Using 25G Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Pancreatic Mass Lesions
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare the number of passes required for cellblock acquisition with and without suction using the 25g needle.


Eligibility criteria: Inclusion Criteria:

* All patients referred to UAB Endoscopy Unit for assessment of pancreatic mass lesions that requires FNA.

Exclusion Criteria:

* Age \< 19 years

  * Unable to safely undergo EUS for any reason
  * Coagulopathy (INR\>1.6, Prothrombin Time\>18 secs, Thrombocytopenia \< 80,000 cells/ml)
  * Unable to consent
  * Non-English speaking patients

Primary outcomes:
measure: Number of passes
timeFrame: once at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jayapal Ramesh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02191215: Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS
Official title: Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 442
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexican patients infected by HIV/AIDS

Brief summary: The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of nevirapine in the management of the HIV/AIDS in an open environment.


Eligibility criteria: Inclusion Criteria:

* diagnosis of HIV/AIDS, no age limits
* patients could be naïve to treatment or pretreated with other antiretroviral agents

Exclusion Criteria:

* Patients with known hypersensitivity to nevirapine or any other component of the product

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline, up to 90 days
measure: Change in cluster of differentiation 4 (CD4) cell count
timeFrame: Baseline, up to 90 days
measure: Change in viral load (HIV RNA)
timeFrame: Baseline, up to 90 days
measure: Number of patients with adverse event
timeFrame: up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06530615: Investigation of MP Pollution in the Human Respiratory System and Its Relationship to Lung Cancer
Official title: Investigation of Microplastic Pollution in the Human Respiratory System and Its Relationship to Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Microplastic Pollution
Human Respiratory System
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any Moffitt patient undergoing bronchoscopy/bronchoalveolar lavage (BAL) either English or Spanish speaking.

Brief summary: This project will study and characterize Microplastic (MP) burden in the lungs of patients undergoing Bronchoalveolar Levage (BAL) in thoracic clinics at Moffitt.


Eligibility criteria: Inclusion Criteria:

* English or Spanish-speaking patients scheduled for bronchoscopy/bronchoalveolar lavage (BAL) in thoracic clinics at Moffitt.

Exclusion Criteria:

* Patients with a known prior history of lung cancer or that have undergone a Bronchoalveolar Lavage (BAL) procedure at any time in the past in the involved lung targeted for BAL.
* Patients that have had any prior lung or thoracic or surgeries or procedures (examples: removal of lung or portions of the involved lung (lobectomy, pneumonectomy, wedge resection/segmentectomy).
* Patients with specimens that are considered to be non-adequate as true Bronchoalveolar Lavage Fluid (BALF) (i.e., absence of alveolar macrophages) after pathologist's evaluation will be excluded from the study.

Primary outcomes:
measure: Characterization of Microplastic (MP) Burden in the Lungs
timeFrame: Up to 24 Months
Secondary outcomes:
measure: Concentration of Microplastics (MPs) in Lung Cancer Patients
timeFrame: Up to 24 Months
measure: Concentration of Microplastics (MPs) in Non-Lung Cancer Patients
timeFrame: Up to 24 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Kathleen M Egan, ScD
role: PRINCIPAL_INVESTIGATOR
References: