louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03489941: A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
Official title: A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle in the Treatment of Ocular Itching Associated With Allergic Conjunctivitis as Induced by the Conjunctival Allergen Challenge Model (Ora-CAC®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2018-04-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years old
* have a positive history of allergic conjunctivitis and positive skin test reaction to allergens
* be willing to avoid disallowed medications for the appropriate washout period and throughout the trial
* be willing to avoid contact lens use
* be willing to have a pregnancy test
* must be able to read an eye chart from 10 feet away

Exclusion Criteria:

* must not have any allergies to the study medications
* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
* must not have used an investigational drug or device in the past 30 days or currently be enrolled in another investigational trial

Primary outcomes:
measure: Ocular Itching
timeFrame: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Secondary outcomes:
measure: Conjunctival Redness
timeFrame: 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
Study officials:
References:
Clinical trial NCT01907841: The Effect of Ischemic Pre-Conditioning on the Rate of Recovery Following Exercise-Induced Muscle Damage
Official title: The Effect of Ischemic Pre-Conditioning on the Rate of Recovery Following Exercise-Induced Muscle Damage: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise-induced Muscle Damage
Keywords: Investigate IPC on EIMD
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle damage and changes in muscle function; this is known as exercise-induced muscle damage (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as in various other organs.

Therefore the purpose of this study is to:

1. Quantify the use of IPC in recovery following EIMD.
2. Identify any effect of IPC during recovery on muscle function


Eligibility criteria: Inclusion Criteria:

* Physically Active Males

Exclusion Criteria:

* Muscular skeletal disorders

Primary outcomes:
measure: Change from baseline in maximal voluntary contraction
timeFrame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Secondary outcomes:
measure: Change from baseline in Creatine kinase
timeFrame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
measure: Change from baseline in Limb girth
timeFrame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
measure: Chnage from baseline in Vertical jump
timeFrame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
measure: Change from baseline in Muscle soreness
timeFrame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Marys Umiversity College
Study officials:
References:
Clinical trial NCT00067041: Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft
Official title: A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Remodulin in Patients With Critical Limb Ischemia Following an Autogenous Vein Infrainguinal Bypass Graft
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Peripheral Vascular Disease
Keywords: Critical Limb Ischemia
Autogenous Bypass Graft
CLI
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2003-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.


Eligibility criteria: * Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Memorial Health Center
state: Massachusetts
city: Albany
country: United States
facility: Vascular Institute Albany Medical College
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
References:
Clinical trial NCT02403141: Abu Dhabi Sleep Apnea (ADSA) Study
Official title: Abu Dhabi Sleep Apnea (ADSA) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnoea
Lead sponsor: Imperial College London Diabetes Centre
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 attending ICLDC will be offered the option of taking part in the study. Those agreeing to participate will be asked to fill in a questionnaire.

Brief summary: Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing awareness, remains under-diagnosed. There is a close association between OSA and obesity; 60-70% of patients diagnosed with OSA are either obese or overweight \[1\]. OSA is also very common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain through sleep disturbance \[2\]. Several mechanisms have been proposed for the associations of OSA with diabetes and obesity \[3\]. At present there is little available information regarding the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the impact of OSA on health outcomes in the Emirati population. This research will explore these relationships and inform public health decisions regarding diagnostic pathways, service provision and treatment protocols.


Eligibility criteria: Inclusion Criteria:

Participants aged between 18-64 years old. Both Gender male and female.

Exclusion Criteria:

Paediatrics below the age of 18. Any participant who is unable to take part

Primary outcomes:
measure: Primary objective (Establishing the prevalence of OSA in the study population.)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Imperial College London Diabetes Centre
Study officials:
References:
Clinical trial NCT03957941: FamilyLink and Breastfeeding
Official title: Impact of Visual Contact With the Premature Infant on Maternal Breast Milk Expression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 39
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to the order of Intervention and Control pumping session. Excluding the first pumping session of the day, as the volume is highest at that time and more consistent throughout the rest of the day. All 30 mothers will be asked to A (Control): Pump three times while they are away from their infant without using FamilyLink for video observation of their baby during pumping and B (Intervention): Pump three times while they are away from their infant, while watching their baby via FamilyLink.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The central hypothesis guiding this project is that having mothers view live video of their babies while they are pumping increases milk volume, caloric density, and maternal pumping experience.


Eligibility criteria: Inclusion Criteria:

* Mothers of 30 preterm infants (born before 34 weeks gestational age) admitted to the University of California, Davis neonatal intensive care unit (NICU)
* Mother is pumping breastmilk
* Delivery at least 7 days prior
* Mother not an inpatient,

Exclusion Criteria:

* Mother has HIV
* Mother without access to a computer, smartphone, or tablet to access FamilyLink
* Infant delivered via surrogacy
* Maternal age outside limit of 18 to 50

Primary outcomes:
measure: Mean volume of Breast Milk
timeFrame: Two days
Secondary outcomes:
measure: Pumping Efficiency
timeFrame: Three times per day for two days
measure: FamilyLink breast milk fat content
timeFrame: One day
measure: Standard breast milk fat content
timeFrame: One day
measure: FamilyLink breast milk protein content
timeFrame: One day
measure: Standard breast milk protein content
timeFrame: One day
measure: FamilyLink breast milk carbohydrate content
timeFrame: One day
measure: Standard breast milk carbohydrate content
timeFrame: One day
measure: Quantitative pumping experience
timeFrame: Three times per day for two days
measure: Qualitative pumping experience
timeFrame: Two days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Laura Kair, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoyt-Austin AE, Miller IT, Kuhn-Riordon KM, Rosenthal JL, Chantry CJ, Marcin JP, Hoffman KR, Kair LR. Bonding, Relaxation, Separation, and Connection: Expressing Human Milk While Videoconferencing with the Hospitalized Premature Infant. Breastfeed Med. 2022 Aug;17(8):653-659. doi: 10.1089/bfm.2021.0214. Epub 2022 May 23.
Clinical trial NCT04944641: Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
Official title: Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: epilepsy prevalence, intervention
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Hangzhou Center of Disease Control and Prevention
name: The Central Hospital of Lishui City
name: The Second Affiliated Hospital of Jiaxing University
name: Zhejiang University
name: Children's Hospital Affiliated to Zhejiang University School of Medicine
First posted: 2021-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomly group into two
Primary purpose: OTHER

Brief summary: To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention to help patients with epilepsy to improve seizure control and the quality of life.

Detailed description: To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention（proper antiepileptic drugs and education intervention） to help patients with epilepsy to improve seizure control and the quality of life.

Eligibility criteria: Inclusion Criteria:

Newly diagnosed and untreated epilepsy; Aged 14 and above; Sign the informed consents.

Exclusion Criteria:

With intellectual development disorder; With serious heart and lung diseases.

Primary outcomes:
measure: Change from baseline seizures frequency 1
timeFrame: 12 months
measure: Change from baseline seizures frequency 2
timeFrame: 24 months
measure: Occurrence of refractory epilepsy
timeFrame: 24 months
Secondary outcomes:
measure: Quality of life (QOL scales)
timeFrame: 2 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
city: Shengzhou
country: China
facility: Shengzhou People's Hospital
Study officials:
References:
Clinical trial NCT02240641: Effect of Caldine® on Renal Function in Balanced Hypertension
Official title: Study on Protective Effect of Caldine® on Renal Function in Patients With a Balanced Hypertension
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 5417
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: patients with hypertension requiring treatment

Brief summary: The study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies.

Due to the contract research organisation (CRO) decision in September 2000, the database was locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to stop the study and not proceed to the analysis. Thus, only safety data were processed in the safety database.


Eligibility criteria: Inclusion Criteria:

* patients with hypertension requiring treatment

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03790241: In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion
Official title: In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: catheter insertion
puncture
skin
vein
palpation
motion tracking
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The aim of this study is to analyze the palpation and perforation motion performed by the practitioner during the insertion of a catheter while measuring the loads applied on the skin and the veins.

These experimental measures will be used for the design of a more realistic peripheral venous catheter insertion simulator in order to better prepare healthcare students for their first in vivo venous puncture.


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteer
* Aged between 18-25 yo or 60-75 yo
* IBM between 18,5-25 or superior or equal to 30
* Cognitive level compatible with oral communication, respect of safety instructions and understanding of realized acts
* Signed the study agreement

Exclusion Criteria:

* Individuals displaying coagulation disorders
* Individuals displaying skin lesions, scars or areteriovenous fistula on the ventral side of the forearm
* Individuals displaying a high infection risk
* Women that have been subject to a lymph node dissection on a malignant breast tumor
* Individuals not able to express their consent
* Individuals having a hierarchical link with the persons conducting this study
* Individuals currently participating to another research which includes an exclusion period

Primary outcomes:
measure: Punctures forces of the skin and veins measured by an instrumented syringue
timeFrame: Day 0 (at intervention)
measure: Needle velocity during perforation measured by a flexible piezoresistive sensor
timeFrame: Day 0
measure: Needle insertion angle during perforation measured by digital image correlation
timeFrame: Day 0
measure: Loads applied by the palpating finger to locate the vein to puncture, measured by digital image correlation
timeFrame: Day 0
measure: Spatial displacement of the palpating finger measured by digital image correlation
timeFrame: Day 0
Secondary outcomes:
measure: Age
timeFrame: Day 0
measure: Sex
timeFrame: Day 0
measure: Weight
timeFrame: Day 0
measure: Height
timeFrame: Day 0
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT03609541: Evaluation of Biomarkers of COPD Exacerbation
Official title: Evaluation of Biomarkers of COPD Exacerbation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SAA Level and SAA/Lipoxin A4 Ratio
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test (stable COPD and COPD exacerbation)

Brief summary: Serum amlyoid A (SAA) was shown to act as biomarker for exacerbation of chronic obstructive pulmonary disease (AE-COPD). It seems that SAA triggers chronic inflammation by binding to ALX/PFR2 receptor. In contrast, lipoxin A4 seems to inhibit the inflammatory processes by binding to ALX/PFR2 receptor. A small trial has already demonstrated an imbalance between SAA and lipoxin A4 during AE-COPD. This study evaluates SAA level and SAA/lipoxin A4 ratio in patients with stable COPD and AE-COPD.

Detailed description: Patient enrolment and data aquisition is to be carried out on a prospective basis. It is planned to enrol 40 patients with stable COPD and 40 patients with AE-COPD. All patients will undergo blood sampling inlcuding SAA and Lipoxin A4.

Eligibility criteria: Inclusion Criteria:

* Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test
* Patient has provided written informed consent

Exclusion Criteria:

* other reasons for worsening of symptoms (cough, dyspnea): e.g. pneumothorax, pneumonia, pulmonary embolism, myocardial infarction.
* malignant disease

Primary outcomes:
measure: SAA
timeFrame: time of exacerbation/hospitalisation, an average of 3 days
measure: SAA/lipoxin A4 ratio
timeFrame: time of exacerbation/hospitalisation, an average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
Study officials:
affiliation: Thoraxklinik University of Heidelberg
name: Daniela Gompelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01959841: Phase III Study of ASP2151 in Herpes Zoster Patients
Official title: Phase III Study of ASP2151 in Herpes Zoster Patients- A Double-blind, Valaciclovir-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 751
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.

Detailed description: A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment" to demonstrate the non-inferiority of ASP2151 to VACV. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Eligibility criteria: Inclusion Criteria:

(1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash

Exclusion Criteria:

1. Patients who are not expected to have an adequate response to oral antiviral medication
2. An extreme decline in immune function
3. Presence of serious complications
4. Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

   * AST or ALT ≥ 2.5 x upper limit of normal
   * Platelet count \< lower limit of normal
   * Serum creatinine ≥ 1.5 mg/dL
   * Creatinine clearance \< 50 mL/min
5. Current or previous history of malignant tumor within 5 years before informed consent
6. Diagnosis of autoimmune disease
7. Evidence of bone marrow suppression

Primary outcomes:
measure: The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment
timeFrame: 4days
Secondary outcomes:
measure: Time to Cessation of New Lesion Formation
timeFrame: 29days
measure: Time to Complete Crusting
timeFrame: 29days
measure: Time to Healing
timeFrame: 29days
measure: Time to Pain Resolution
timeFrame: 29days
measure: Time to Virus Disappearance
timeFrame: 29days
Other outcomes:
Locations:
city: Sapporo
country: Japan
state: Hokkaido
city: Yokohama
country: Japan
state: Kanagawa
city: Nakano-Ku
country: Japan
state: Tokyo
Study officials:
affiliation: Clinical Development Department
name: Maruho Co.,Ltd. Kyoto R&D Center
role: STUDY_DIRECTOR
References: