louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04366076: Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?
Official title: Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Conditions
Fetal Movement Disorder
Keywords: Fetal hiccups
fetal movement
computerised cardiotocography
cardiotocography
computerized analysis
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physiological nonlaboring term singleton pregnancies (\>37 weeks) without maternal or fetal complication

Brief summary: BACKGROUND: The physiological function of fetal hiccups and its correlation with fetal well-being is unexplored. No previous study examines the correlation between the maternal perception of the fetal hiccups and the antepartum cardiotocography.

OBJECTIVE: To evaluate the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.


Eligibility criteria: Inclusion Criteria:

* physiological nonlaboring term singleton pregnancies

Exclusion Criteria:

* . Gestations complicated by fetal malformations, stillbirth, preterm deliveries or patients with missing data were excluded.

Primary outcomes:
measure: The primary outcome was the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.
timeFrame: pre-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
state: Italia
Study officials:
References:
Clinical trial NCT01035476: Optimizing NIPPV Use for Patients With ALS
Official title: Effectiveness Trial of Detailed NIPPV Feedback to Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALS
Keywords: ALS
nasal ventilation
data card recording
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: ALS Association
First posted: 2009-12-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will examine the utility of the data card recording capacity of nasal ventilation devices (NIPPV) in people with ALS to optimize use.

Detailed description: The data card records critical features of NIPPV acceptance (hours and timing of use) and adherence (apnea/hypopnea index, mask leak, minute ventilation); but to date data card monitoring has not yet been incorporated fully into ALS clinic practice. We will limit our focus to patients who meet Medicare-reimbursement criteria or AAN-recommended practice parameters for initiating NIPPV. The larger question guiding this research is whether data card monitoring and communication of these results to clinicians and patient families promotes "optimal use" of NIPPV. We define optimal use as (i) high acceptance, as indicated by daily night time use greater than 4 hours, and (ii) high adherence, as indicated by apnea/hypopnea index, mask leak, and minute ventilation. We will test whether timely reporting of acceptance and adherence values to patients and clinicians increases the likelihood of (i) changes in orofacial masks and settings on devices and continued use of devices, and (ii) positive patient mood and sleep quality and lower caregiver burden over follow-up.

Eligibility criteria: Inclusion Criteria:

* Definite or probable ALS
* Medicare or AAN criteria for initiating NIPPV
* Community resident
* English speaker

Exclusion Criteria:

* Unable to give informed consent
* Other pulmonary or cardiac conditions that complicate use of NIPPV
* Report from physician that participation would be harmful

Primary outcomes:
measure: Length of time on NIPPV
timeFrame: 6 months
Secondary outcomes:
measure: Patient sleep quality, mood, fatigue
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven Albert, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: David Lacomis, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05748327: Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Official title: Randomized Controlled Clinical Trial (RCT) of the New Tooth-colored Restorative Material 'Cention Forte' (Ivoclar Vivadent) vs. 'Equia Forte HT' (GC) in Class-I/II Cavities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caries
Defective Restorations
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
Collaborators: name: KU Leuven
First posted: 2023-02-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-Mouth Design
Primary purpose: TREATMENT

Brief summary: This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).

Detailed description: The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.

Eligibility criteria: Inclusion Criteria:

* Subject's age between 18 and 65 years old
* Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars
* Vital teeth
* 2 restorations per patient: both cavities should have comparable size and dimensions
* Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included)
* Low to moderate caries rate/normal periodontal status with good home care

Exclusion Criteria:

* Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)
* Pulp exposure or signs of pulpal infection
* No signs of pulpitis or hypersensitivity (Visual analog scale \< 3 on biting and temperature sensitivity)
* History of allergy to glass ionomer, acrylate/methacrylate monomers
* Pregnancy
* Chronic disease with oral manifestations or primary oral pathology
* Bad oral hygiene
* High caries rate or periodontal problems
* Absence of antagonists
* Absence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)

Primary outcomes:
measure: Success Rate
timeFrame: 5 years
Secondary outcomes:
measure: Success Rate
timeFrame: 6 months to 3 years
measure: Survival Rate
timeFrame: 6 months to 5 years
measure: Quality criteria (Clinical performance)
timeFrame: 6 months to 5 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
Clinical trial NCT01238627: Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg
Official title: Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg - A Study in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation
Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.

Detailed description: The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational products will be given as single doses at separate visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood will be sampled at each treatment visit for pharmacokinetic analyses pre-dose, and at 5, 10, 15, 20, 30, and 45 minutes, as well as 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete product dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. The trial is open in the sense that subjects and study personnel will be aware of what product is administered at a given visit. However, the treatment labels will not be known by the people performing bioanalysis or analyzing pharmacokinetic data.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and Body Mass Index (BMI) between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: During 10 hours post-dose
measure: Area Under the Curve (AUC)(0-t)
timeFrame: During 10 hours post-dose
measure: AUC(0-∞)
timeFrame: 10 hours post-dose
Secondary outcomes:
measure: Product Dissolution Time
timeFrame: During 10 hours post-dose
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00001127: Study of a Flu Vaccine in Children
Official title: Study of the Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in a Community-Based, Non-Randomized, Open-Label Trial in Children to Assess Safety and Herd Immunity for the Control of Epidemic Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Aviron LLC
First posted: 2001-08-31
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: This study tests the safety and effectiveness of a flu vaccine in school children.

School children are usually the first members of a community to come down with the flu, and they often give the flu to their younger siblings, parents, and grandparents. It is hoped that giving school children a flu vaccine can help prevent the spread of the flu to other members of the community.

Detailed description: This is a Phase III trial (an advanced study with a large number of patients). Your child will receive a single dose of flu vaccine, which is given by a nasal spray.

Eligibility criteria: Inclusion Criteria:

Your child may be eligible for this study if he/she:

* Is between the ages of 18 months and 18 years, with consent of parent or guardian.
* Is a resident of the Temple-Belton, Texas area.

Exclusion Criteria:

Your child will not be eligible for this study if he/she:

* Has had a fever within 3 days before vaccination.
* Has symptoms of a weakened immune system.
* Has had a wheezing episode within the past 2 weeks.
* Has moderate to severe asthma.
* Is allergic to eggs.
* Needs to take aspirin on a regular basis.
* Has received another vaccine or study drug in the past month.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Pedro A. Piedra, M.D.
state: Texas
Study officials:
References:
Clinical trial NCT03747627: BPF Genetics of ILD Study
Official title: British Pigeon Fanciers Genetics of Interstitial Lung Disease Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung; Disease, Interstitial, With Fibrosis
Alveolitis, Extrinsic Allergic
Bird Fancier's Lung
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Idiopathic Pulmonary Fibrosis
Keywords: Interstitial Lung Disease (ILD)
Hypersensitivity Pneumonitis
Idiopathic Pulmonary Fibrosis (IPF)
Extrinsic Allergic Alveolitis (EAA)
Bird Fancier's Lung
Genetics
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: University of Glasgow
name: Newcastle University
name: British Lung Foundation
name: British Pigeon Fanciers Medical Research
First posted: 2018-11-20
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the sport of Pigeon racing

Brief summary: The investigators aim to examine the genetic determinants of interstitial lung disease in a cohort of subjects with regular exposure to pigeons, a known cause of one form of interstitial lung disease known as hypersensitivity pneumonitis. In addition we will examine immunological causes for hypersensitivity pneumonitis in this group.

We anticipate our work will provide insights of use to clinicians and patients with hypersensitivity pneumonitis and other interstitial lung diseases.

Detailed description: The investigators aim to recruit participants with regular racing pigeon exposure at national (UK) and regional pigeon fancier meetings.

Consenting subjects will complete questionnaires, provide blood samples for genetic analysis and immunological testing and undertake lung function measurements.

Subjects will be observed, and encouraged to report referral to specialist respiratory services, and following this information will be sought on diagnosis (including supporting evidence). Where interstitial lung disease is detected this will be linked to subsequent unbiased analysis to detect potential predisposing genetic associations.

Eligibility criteria: Inclusion Criteria:

* regular exposure to racing pigeons

Exclusion Criteria:

* Unwilling to participate

Primary outcomes:
measure: Relationship of specific genetic markers to development of interstitial lung disease
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Blackpool
country: United Kingdom
facility: Royal Pigeon Racing Association Meeting
city: Lanark
country: United Kingdom
facility: Scottish Homing Union
Study officials:
affiliation: NHS Tayside & University of Dundee
name: Mark Spears, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leicester
name: Louise Wain, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02281227: Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain Due to Spinal Nerve Compression
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate the effects of skin compression with an indicator at the needle entry point on radiation exposure time of fluoroscopically guided transforaminal epidural block in obese patients


Eligibility criteria: Inclusion Criteria:

* Adult patients with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection

Exclusion Criteria:

* Local anesthetic allergy, coagulopathy

Primary outcomes:
measure: Total radiation exposure time
timeFrame: immediately ≤1 sec after the confirmation of successful epidural injection
Secondary outcomes:
measure: The number of the needle readjustments
timeFrame: immediately ≤1 sec after the confirmation of successful epidural injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00709527: ARC1905 (Anti-C5 Aptamer) Given With Lucentis 0.5 mg In People With Neovascular Age-Related Macular Degeneration
Official title: A Phase 1 Ascending Dose And Parallel Group Trial To Establish The Safety, Tolerability And Pharmacokinetic Profile of Multiple Intravitreous Injections of ARC1905 (Anti-C5 Aptamer) Given In Combination With Multiple Doses of Lucentis® 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: AMD
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis® 0.5 mg/eye, or with one induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram.

Exclusion Criteria:

* Previous or concomitant therapy with intravitreous corticosteroids.
* Any of the following underlying diseases including:
* Diabetic retinopathy
* History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.
* History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
* Clinically significant impaired renal (serum creatinine \>2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. Patients with results outside these ranges may be enrolled in consultation with Ophthotech.
* Stroke (within 12 months of trial entry).
* Any major surgical procedure within one month of trial entry.
* Previous therapeutic radiation in the region of the study eye.
* Any treatment with an investigational agent in the past 60 days for any condition.
* Women who are pregnant or nursing.
* Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the ARC1905 formulation.

Primary outcomes:
measure: Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Ophthotech Corp
state: New York
Study officials:
References:
Clinical trial NCT03035227: Catheter Ablation of Arrhythmias to Improve CRT Response
Official title: Catheter Ablation of Arrhythmias to Improve CRT Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arrhythmia, Cardiac
Lead sponsor: Kansas City Heart Rhythm Institute
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2017-01-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.


Eligibility criteria: Inclusion Criteria:

* Heart failure patients with CRT-D or CRT-P greater than 3 months
* Bi-ventricular pacing less than 94% of the time
* 3 months after CRT-D or CRT-P implantation an EF improvement less than 5%
* Presence of one of the following arrhythmias and eligible for catheter ablation:
* Atrial fibrillation
* Atrial flutter
* Supraventricular tachycardia
* Premature ventricular contraction burden greater than 30% in a 24-hour period
* Ventricular tachycardia

Exclusion Criteria:

* Estimated survival less than one year
* Patient unable to make scheduled follow up visits at treating center
* Participating in another investigational study

Primary outcomes:
measure: Change in Ejection Fraction (EF)
timeFrame: 90 Days
measure: Bi-ventricular Pacing Improvement
timeFrame: 90 Days
measure: Cardiovascular Mortality
timeFrame: 365Days
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 365 Days
measure: Hospital Admissions for Heart Failure Exacerbation
timeFrame: 365 Days
measure: New York Heart Association (NYHA) Class Change
timeFrame: 30 Days
measure: Change in 6 Minute Walk Test
timeFrame: 30 Days
measure: Change in Quality of Life - SF-36
timeFrame: 30 Days
measure: Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 Days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References: