louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02064751: MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics
Official title: Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 40
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: The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).


Eligibility criteria: Inclusion Criteria:

* Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system
* Be in NYHA II or III functional class with approved standard indication by ESC/EHRA Guidelines
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria:

* Have persistent or permanent atrial fibrillation
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months
* Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Be scheduled or considered for heart transplantation over the next 12 months
* Be less than 18 years of age
* Be pregnant or plan to become pregnant over the next 12 months

Primary outcomes:
measure: Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
timeFrame: up to 6-months
Secondary outcomes:
measure: echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements
timeFrame: 6 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Rennes
country: France
facility: CHU Rennes
city: Milan
country: Italy
facility: Niguarda Hospital
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: University Hospital Rennes, Rennes, France
name: Christophe Leclercq, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01583751: Videoendoscopic Pilonidal Sinus Surgery
Official title: Videoendoscopic Pilonidal Sinus Surgery. A New Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recurrence
Postoperative Complication
Keywords: pilonidal sinus
new technique
videoendoscopic
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.

Detailed description: Lots of surgical techniques are performing on pilonidal sinus disease treatment. Lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. In this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. One hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues.

Eligibility criteria: Inclusion Criteria:

* symptomatic pilonidal sinus disease
* primer pilonidal sinus disease
* noncomplicated pilonidal sinus disease

Exclusion Criteria:

* Asymptomatic pilonidal sinus disease
* Recurrence pilonidal sinus disease
* complicated pilonidal sinus disease

Primary outcomes:
measure: recurrence rates
timeFrame: six months
Secondary outcomes:
measure: postoperative complications, wound healing
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: erhan aysan, assoc prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03472651: Bioequivalence Study to Compare Two Formulations of Deanxit®
Official title: Interventional, Randomized, Single Dose, Open-label, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®) - in Fasted and Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition


Eligibility criteria: Inclusion Criteria:

* Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 28 kg/m2.
* Women must be non-pregnant and non-lactating

Primary outcomes:
measure: AUC0-72h: flupentixol
timeFrame: from zero to 72 hours post-dose
measure: Cmax: flupentixol
timeFrame: from zero to 72 hours post-dose
measure: AUC0-72h: melitracen
timeFrame: from zero to 72 hours post-dose
measure: Cmax: melitracen
timeFrame: from zero to 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: CN1036 Shijitan Hospital
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT03710551: Happy Smooth Study
Official title: Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Term Birth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.

Detailed description: Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.

Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Infants whose parents/LAR have reached the legal age of majority in the Philippines
* Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol
* Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study
* Healthy term, singleton infant at birth
* Between 21 to 28 days post-natal age at enrollment visit
* Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts
* Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

Exclusion Criteria:

* Infants with conditions requiring infant feedings other than those specified in the protocol
* Infants receiving complementary foods or liquids
* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
* Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results

Primary outcomes:
measure: Stool Consistency Score
timeFrame: Study Day 57, corresponding to infant age of 78-85 days
Secondary outcomes:
measure: GI Tolerance
timeFrame: which corresponds to infant age of 21-28, 43-50, and 78-85 days.
measure: Changes in Weight from baseline to 57 days
timeFrame: Study Day 57, corresponding to infant age of 78-85 days
measure: Changes in Length from baseline to 57 days
timeFrame: Study Day 57, corresponding to infant age of 78-85 days
measure: Changes in Head Circumference from baseline to 57 days
timeFrame: Study Day 57, corresponding to infant age of 78-85 days
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
Study officials:
affiliation: University of Alberta
name: Elvira M Estorninos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02396251: Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation
Official title: A Multi-Centre, Evaluator-Blinded Study to Evaluate Efficacy and Safety of R Volumizer for Cheek Augmentation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Facial Tissue Augmentation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.


Eligibility criteria: Inclusion Criteria:

* Provide a signed and dated informed consent to participate in the study including release of copyright of images
* Man or woman aged 18 years or older
* Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable HA gel
* History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment
* Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment
* Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated
* The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason

Primary outcomes:
measure: Percentage of Responders in Midface Fullness Using Photo Scale
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Responders in Midface Fullness Using Photo Scale
timeFrame: 15 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References:
Clinical trial NCT04952454: Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques
Official title: Non-endoscopic Endonasal, Transcanalicular, or External Dacryocystorhinostomy for Functional Epiphora: Which is Better?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Epiphora (Tearing Without Any Anatomical Block)
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 135
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 135 eyes of 135 patients treated between 2005 and 2017 will be included in this study. The diagnosis of functional epiphora was made based on a patent lacrimal system with a delay in the fluorescein dye disappearance test (FDDT) or dacryoscintigraphy (DSG) without any ocular surface or eyelid abnormalities. The absence of epiphora and normalization of FDDT postoperatively was defined as success. The study's hypothesis is that external DCR with a suitable technique will have better results compared to endonasal and transcanalicular DCR


Eligibility criteria: Inclusion Criteria:

* patent lacrimal irrigation and delay in the lacrimal transit time demonstrated by fluorescein dye disappearance test (FDDT) or a dacryoscintigraphy (DSG)

Exclusion Criteria:

* Dry eye (tear break up time less than 10 seconds), ocular surface disorders, eyelid malposition or laxity, orbicularis weakness, partial block or stenosis of the lacrimal drainage, history of previous nasal, lacrimal, or ophthalmic surgeries, and a postoperative follow-up time less than six months

Primary outcomes:
measure: Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.
timeFrame: Last follow-up time, approximately 6 months
Secondary outcomes:
measure: Number of patients who have continuing epiphora after the surgery with an anatomically blocked tear duct.
timeFrame: Last follow-up time, approximately 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Istanbul
country: Turkey
facility: Beyoglu Eye Research Hospital
Study officials:
affiliation: Istanbul University, Istanbul Facukty Of Medicine
name: Can Ozturker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04211454: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Migraine Headaches
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Migraine Headaches
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Migraine
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with migraine headaches

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Migraine Headaches.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages.
3. Diagnosis of migraine headaches by a physician

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02378454: Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children
Official title: Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children: A Comparison of Two Commercially Available Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Healthy
Keywords: Lung Clearance Index
Cystic Fibrosis
Multiple Breath Nitrogen Washout
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF : primary care clinic HC : community sample

Brief summary: This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.

Detailed description: Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).

Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis diagnosis

Exclusion Criteria:

* Respiratory infection within 3 weeks
* Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia

Primary outcomes:
measure: Lung Clearance Index (LCI)
timeFrame: 1 hour
Secondary outcomes:
measure: Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device)
timeFrame: 1 hour
measure: Spirometry
timeFrame: 20 minutes
Other outcomes:
measure: Subject's preference
timeFrame: 1 hour
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Patrick Lebecque, MD, PhD
role: STUDY_DIRECTOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: William Poncin, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Anne-Sophie Aubriot, PhD student
role: STUDY_CHAIR
References:
Clinical trial NCT00055354: Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
Official title: Acupuncture Diagnosis and Treatment of DSM-IV PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Acupuncture
Medicine, Chinese Traditional
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-02-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate acupuncture as a treatment for Post-Traumatic Stress Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine (TCM) diagnostic patterns.

Detailed description: This study will evaluate: 1) the TCM diagnostic differentiation patterns of people who have PTSD as defined by the Diagnostic and Statistical Manual, 4th edition; 2) if an acupuncture treatment approach is acceptable to people with PTSD; and 3) if an acupuncture treatment approach is associated with a reduction in PTSD symptoms that is comparable to that of standard treatments. Because symptoms of depression, insomnia, and pain are often associated with PTSD, we will also evaluate the potential benefit of an acupuncture approach to depression, insomnia, and pain symptoms in people with PTSD.

Patients in this study will be randomized to one of three groups. Group A will receive acupuncture therapy. Group B will receive standard Cognitive Behavior Therapy. Group C is a control group and will receive no treatment. Patients in Groups A and B will undergo a total of 24 hours of therapy over the 3 month study course. All patients will have five nontherapeutic study visits; these visits will address diagnosis and assessment. Study visits will include assessments of PTSD symptoms, sleep symptoms, and level of impairment.

Eligibility criteria: Inclusion Criteria

* DSM-IV diagnosis of PTSD
* Stage I PTSD symptoms
* PTSD Symptom Scale-Self Report (PSS-SR) score \> 16
* Meets PSS-SR diagnostic criteria

Exclusion Criteria

* Stage I substance abuse and/or dependence in the past 6 months
* Psychotic disorder
* Inability to commit to treatment or wait-list conditions
* Current treatment specifically for PTSD
* Certain medical conditions, including thyroid disease, class IV heart failure, active cancer treatment, and uncontrolled diabetes
* Pregnant
* Use of benzodiazepines, narcotics, opiates, narcotic antagonists, sleep medication, muscle relaxants, analgesics, or sedatives.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center- Department of Psychiatry
state: New Mexico
Study officials:
References:
Clinical trial NCT00861354: Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor
Official title: Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor: Trial of Regular vs Irregualr Pulse for the Prevention of Stroke (TRIPPS 2.0)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
home blood pressure monitoring
Lead sponsor: Microlife
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in a general medical practice.

Brief summary: This study assess the accuracy of a blood pressure monitor designed to detect atrial fibrillation. Subjects use the blood pressure monitor on a daily basis for 30 days and compare the readings to an ECG done at the same time.


Eligibility criteria: Inclusion Criteria: any of the following

* age 65 or older
* hypertension
* diabetes mellitus
* congestive heart failure
* previous stroke

Exclusion Criteria:

* permanent pacemaker
* impalantable defibrillator

Primary outcomes:
measure: Sensitivity and specificity of the blood pressure monitor used for detecting atrial fibrillation compared to the electrocardiogram.
timeFrame: After final subject data is available.
Secondary outcomes:
measure: Assess subjects understanding of the use of the device for atrial fibrillation.
timeFrame: After final subject data is available.
Other outcomes:
Locations:
city: Flushing
country: United States
facility: Joseph Wiesel, MD medical office
state: New York
Study officials:
name: Joseph Wiesel, MD
role: PRINCIPAL_INVESTIGATOR
References: