louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01459562: First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
Official title: A Randomized Double-blinded Placebo Controlled Single Center Phase I Study of Escalating Single Intravenous Doses of NI-0501 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* healthy adults between 18 and 50 years old
* non smokers
* able to adhere to study protocol requirements

Exclusion Criteria:

* any abnormal clinical safety laboratory parameters

Primary outcomes:
measure: Safety and tolerability of escalating single IV doses of NI-0501.
timeFrame: AEs at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10, 12 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8
Secondary outcomes:
measure: Pharmacokinetics parameters, Determination of any pharmacodynamic effects, Immunogenicity of NI-0501
timeFrame: PK/PD at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8, Immunogenicity: SD1 pre-infusion, Wk 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: HMR
city: Manchester
country: United Kingdom
facility: ICON
Study officials:
affiliation: HMR
name: Steve Warrington, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICON plc
name: Peter Dewland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06057662: Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes
Official title: Effect of Personalized Comprehensive Diabetes Support Among Families of Children With Newly Diagnosed Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if access to a diabetes coach improves quality of life (QOL) for families of children with newly diagnosed type 1 diabetes. The main questions it aims to answer are:

1. Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention.
2. Determine if potential beneficial effects persist beyond completion of the support intervention, as measured by diabetes-related QOL at 12 months and 24 months following diagnosis

Participants assigned to the intervention group will have access to a diabetes coach for 6 months following type 1 diabetes diagnosis. They will be compared to participants who are assigned to the control group and are receiving usual care.


Eligibility criteria: Inclusion Criteria:

* Families of children 16 years of age or younger with a new diagnosis
* Stable living situation such that the same caregivers are anticipated to be caring for the child during the full 2-year study duration.

Exclusion Criteria:

* Families of children older than 16 years
* Children from non-English speaking families

Primary outcomes:
measure: Diabetes Distress Scale
timeFrame: 24 months
measure: Problem Areas in Diabetes (PAID)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
References:
Clinical trial NCT01332162: CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM
Official title: CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM)
Keywords: Hypertrophic Obstructive Cardiomyopathy (HOCM)
Pacing
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2011-04-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.

Detailed description: In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.

Eligibility criteria: Inclusion Criteria:

* Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms

Exclusion Criteria:

* HOCM intraventricular gradient \< 50mmHg
* LV ejection fraction \< 50%
* mild symptoms

Primary outcomes:
measure: Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).
timeFrame: 1 and 2 years
Secondary outcomes:
measure: Change from Baseline in Clinical evaluation of NYHA,QoL,6MWT,interventricular septum thickness,posterior wall thickness,provoked left ventricular outflow tract gradient,mitral regurgitation grade.
timeFrame: 1 and 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: JOSEP BRUGADA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: ANTONIO BERRUEZO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03518762: Sustained Lung Inflation in Preterm Infants
Official title: Effect of Application of Sustained Lung Inflation on the Respiratory Outcome of Preterm Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 160
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.

Detailed description: Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.

Eligibility criteria: Inclusion Criteria:

* Gestational age ≥ 27 weeks and ≤ 32 weeks
* Appropriate for gestational age
* Weight \>800 grams

Exclusion Criteria:

* Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
* Fetal hydrops

Primary outcomes:
measure: Need for invasive mechanical ventilation or death
timeFrame: From birth up to 72 hours of life
Secondary outcomes:
measure: Duration of invasive mechanical ventilation
timeFrame: From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
measure: Pneumothorax
timeFrame: From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days
measure: Bronchopulmonary dysplasia
timeFrame: Assessed at 36 weeks postmenstrual age or discharge, whichever came first
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy Cairo University
Study officials:
References:
citation: Abuel Hamd WA, El Sherbiny DE, El Houchi SZ, Iskandar IF, Akmal DM. Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial. J Trop Pediatr. 2021 Jan 29;67(1):fmaa097. doi: 10.1093/tropej/fmaa097.
Clinical trial NCT03091062: Evaluation of an Airway Clearance System
Official title: Evaluation of the Effectiveness of the Monarch™ Airway Clearance System as Determined by Mucus Production
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 9
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effectiveness of an Airway Clearance System.

Detailed description: The study will compare the effectiveness of The Monarch™ System and The Vest® Airway Clearance System. All subjects will receive treatment with both systems and endpoints will be compared.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of Cystic Fibrosis (CF) (by sweat test and/or genetics)
* Age ≥ 15 years
* Ability to expectorate sputum daily - determined by treating physician
* Patient must be on a stable regimen of CF medication for 4 weeks prior to Visit 1
* Patient who requires regular home airway clearance therapy

Exclusion Criteria:

* Forced Expiratory Volume in 1 Second (FEV1) \< 30 % predicted or \> 90 % predicted
* Anticipated requirement for hospitalization within the next three weeks
* History of pneumothorax within the past 6 months prior Visit 1
* History of haemoptysis requiring embolization within the past 12 months prior to Visit 1
* Inability to perform Monarch™ and/or Vest® System therapy as directed
* Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
* Has taken Intravenous (IV) antibiotics within the past 4 weeks prior to Visit 1
* Has ongoing exacerbation or Allergic bronchopulmonary aspergillosis (ABPA)
* Pregnant or lactating female
* Has a pacemaker or implantable cardioverter defribillator (ICD)

Primary outcomes:
measure: Wet Weight of Sputum Produced
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
measure: Sputum Volume
timeFrame: Through study completion, an average of 2 months
measure: Functional Respiratory Imaging
timeFrame: Through study completion, an average of 2 months
measure: Brody Scores (Scoring of CT Scans)
timeFrame: Through study completion, an average of 2 months
measure: Lung Clearance Index
timeFrame: Through study completion, an average of 2 months
measure: Subjective satisfaction surveys
timeFrame: Through study completion, an average of 2 months
measure: Spirometry
timeFrame: Through study completion, an average of 2 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
Study officials:
References:
Clinical trial NCT04003662: Vital Sign Comparison Between Lifelight and Standard of Care - Development
Official title: Vital Sign Comparison Between Lifelight and Standard of Care - Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vital Signs
Lead sponsor: Xim Limited
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 9000
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The inclusion/exclusion criteria is limited to the proposed intended use of the device, therefore only individuals, of any sex, over the age of 3 will be included in the study.

Brief summary: Patients and volunteers both with and without medical problems will be recruited; vital sign measurements are taken twice with normal equipment and while recording video data at the same time. The data collected will allow the Artificial Intelligence to develop the LifeLight algorithm to to improve measurement accuracy of its video data based vital signs monitor.

Detailed description: Vital signs such as heart rate, blood pressure, breathing rate and oxygen levels currently need several pieces of equipment and trained staff in order to be measured properly. The LifeLight app measures the same vital signs using a camera in a phone, tablet, laptop or smart TV. By using very small changes in the colour of your skin, LifeLight's AI system can calculate these values without any extra equipment or training, and without contact.

The aim of this research study is to improve the accuracy of the LifeLight system with a view to a subsequent Validation study to prove the level of accuracy. The investigators will recruit patients, staff and visitors, both with and without medical problems, and take vital sign measurements twice with normal equipment and while recording video data at the same time. This will allow the AI which develops the LifeLight algorithm to make it more accurate, prior to a subsequent study which will validate the results.

Eligibility criteria: Inclusion Criteria:

* I1. Sufficiently conversant in the English language to satisfy I3.
* I2. Able and willing to comply with all study requirements.
* I3. Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).

Exclusion Criteria:

* There are no exclusion criteria.

Primary outcomes:
measure: Blood Pressure Readings
timeFrame: Single Visit; up to one day
measure: Oxygen Saturation Readings
timeFrame: Single Visit; up to one day
measure: Heart Rate (pulse) Readings
timeFrame: Single Visit; up to one day
measure: Respiratory Rate
timeFrame: Single Visit; up to one day
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
state: England
Study officials:
References:
Clinical trial NCT00332462: A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
Official title: A Multicenter, Open-label, Exploratory Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine During the First 7 Days Post Transplant Followed by Treatment With Cyclosporine Micro Emulsion in de Novo Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: Liver transplantation, Cyclosporine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.


Eligibility criteria: Inclusion Criteria

* About to undergo a primary liver transplant (including living donor, split liver).
* Expected to be capable of study participation for full 6 months post-transplantation.
* Allograft biopsies will be possible.

Exclusion Criteria

* The surgery is a multi-organ transplant.
* The patient has previously been transplanted with any other organ.
* The graft derives from a non-heart beating donor.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation
timeFrame: 3 months
Secondary outcomes:
measure: Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation
timeFrame: 3 or 6 months after transplantation
Other outcomes:
Locations:
city: Various Cities
country: Germany
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03209362: SI-613 Study for Knee Osteoarthritis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Knee
Osteoarthritis
Intra-articular injection
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
Collaborators: name: Chiltern International Inc.
First posted: 2017-07-06
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.


Eligibility criteria: Inclusion Criteria:

* Provides their written informed consent.
* Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
* Is willing to switch to using acetaminophen as a rescue medication

Exclusion Criteria:

* Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
* Secondary OA
* Is a female subject who is pregnant or lactating.
* Is currently hospitalized or has a planned hospitalization during the life of the study.

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
timeFrame: Baseline over 12 weeks
Secondary outcomes:
measure: Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26
timeFrame: Baseline, Weeks 12 and 26
measure: Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26
timeFrame: Baseline, Weeks 12 and 26
measure: Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26
timeFrame: Baseline, Weeks 12 and 26
measure: Change From Baseline in WOMAC Total Score at Weeks 12 and 26
timeFrame: Baseline, Weeks 12 and 26
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Miami
country: United States
facility: MM Medical Center, Inc.
state: Florida
city: Miami
country: United States
facility: Quality Research and Medical Center, LLC
state: Florida
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02502162: Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
Official title: Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Regional Pain Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of complex regional pain syndrome (CRPS). Study participants will be randomly assigned to receive either LDN or placebo for a period of several weeks. During this period participants will be asked to attend either in-person or virtual study visits and complete questionnaires.


Eligibility criteria: Inclusion Criteria:

* Upper and/or lower extremity CRPS
* On stable treatment for 1 month
* CRPS for at least 1 year
* Meet the Budapest criteria for CRPS at time of the study.

Exclusion Criteria:

* Any known allergy to naltrexone or naloxone
* Use of prescription opioid analgesics or illegal opioid use
* Current or planned pregnancy.

Primary outcomes:
measure: Changes in pain severity
timeFrame: Approximately 4 weeks after conclusion of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sean Mackey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01832662: Coffee Polyphenols Antioxidants
Official title: Coffee Antioxidant Efficacy in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (10d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as beneficial as the whole beverage in reducing oxidative stress compared to placebo

Detailed description: This is an interventional study with a crossover randomized placebo-controlled double-blind design to assess the effect of regular consumption of coffee on oxidative stress compared to placebo.

Eligibility criteria: Inclusion Criteria:

* 20 - 70 years, male and female
* healthy
* BMI 19 - 29 kg/m2
* Coffee drinkers with an average consumption of 1-3 cups per day
* having given informed consent

Exclusion Criteria:

* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer- Have had a gastrointestinal surgery, except appendicectomy
* Difficulty to swallow
* Have a regular consumption of medication
* Have taken antibiotic therapy within the last 6 months
* Alcohol consumption \> 2 units a day
* Smokers (more than 5 cigarettes per day)
* Have given blood within the last 3 weeks
* Volunteers who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial during the last 3 weeks

Primary outcomes:
measure: oxidative stress
timeFrame: Change in plasma and in urine beta isoprostane from baseline to the last day of a 10-day period of product intake
Secondary outcomes:
measure: bioavailability of coffee phenolics
timeFrame: Change of plasma chrorogenic and phenolic acids from baseline to the last day of a 10-day period of product intake
Other outcomes:
Locations:
Study officials:
affiliation: Nestlé Clinical Development Unit
name: Maurice Beaumont, MD
role: PRINCIPAL_INVESTIGATOR
References: