louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00613106: Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)
Official title: Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Rheumatoid Arthritis
Chronic Low Back Pain
Chronic Regional Pain Syndrome
Chronic Soft Tissue Pain
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 179
Sex: ALL
Minimum age (years): 40
Maximum age (years): 81
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 evaluate the safety of long-term treatment with HZT-501.

Detailed description: Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303.

Study with completed results acquired from Horizon in 2024.

Eligibility criteria: Inclusion Criteria:

* Expected to continue to require daily administration of an NSAID for at least the coming 6 months.
* Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303

Exclusion Criteria:

* Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303
* Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303
* Malignant Disease of the gastrointestinal tract
* Erosive esophagitis
* Clinically significant cardiac, renal or hepatic disease
* Uncontrolled diabetes
* Positive pregnancy test on Study Day 0
* Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: PRA International
state: California
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04565106: Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure
Official title: Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Hypoxemic Respiratory Failure
Hypoxemia
Keywords: O2matic
Closed-loop
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
First posted: 2020-09-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted with COVID-19 pneumonitis and in need of oxygen supplementation

Brief summary: Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Detailed description: Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion
* Need oxygen supply to maintain SpO2 ≥ 92 %
* Able to comply with continuous measurement of SpO2 by pulse oximetry.

Exclusion Criteria:

* Need of oxygen supply \> 10 liters/min at admission

Primary outcomes:
measure: Time in SpO2 target
timeFrame: 1 week
Secondary outcomes:
measure: Time with SpO2 not more than 2 % outside target
timeFrame: 1 week
measure: Time with SpO2 more than 2 % outside target
timeFrame: 1 week
measure: Time with SpO2 < 85 %
timeFrame: 1 week
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Ove Andersen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03392506: EBUS-TBNA-RTE VS Radiography in Staging of NSCLC
Official title: A Control Study of Intrathoracic Lymph Node in NSCLC Staging by EBUS-TBNA-RTE and Radiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: CP-EBUS
EBUS-TBNA
Real time elasticity
Staging of lung cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis.

Detailed description: The newly developed convex array can be used to identify the hardness of the lymph nodes and estimate the benign and malignant lymph nodes indirectly through the quantitative and visualized analysis of the elastic coefficient of the bronchus through the CP-EBUS elastography mode.

The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis.

120cases will be enrolled.Compared with the commonly used methods to evaluate intrathoracic lymph node metastasis, the accuracy of chest CT and PET-CT were compared. The lymph node staging method and the final pathological gold standard of the three groups were compared, so as to verify the accuracy and clinical popularization of the bronchial ultrasound elastography mode.

Eligibility criteria: Inclusion Criteria:

1. Intrathoracic lymph node enlargement
2. EBUS-TBNA operation can be performed

Exclusion Criteria:

1. Unable to cooperate with the experiment

Primary outcomes:
measure: The effectiveness of EBUS-TBNA-RTE
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04306406: Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation
Official title: Molecular Mechanisms Underlying the Protective Effects of Whole Red Raspberries Against Insulin Resistance and Inflammation in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Insulin Resistance
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Processed Raspberry Council
name: Louisiana State University and A&M College
First posted: 2020-03-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Red raspberries (Rubus idaeus) are a good source of health enhancing hydrolyzable and condensed tannins, flavonoids, anthocyanins, phenolic acids, rheosmin, potassium, carotenoids, vitamin C, and vitamin K1. Compared to other berries commonly consumed in the US, the health benefits of red raspberries to improve pre-diabetes mellitus (PDM) and type 2 diabetes have never been explored. The clinical study proposed in this project seeks to investigate the protective effect of whole red raspberries against insulin resistance, oxidative stress, and inflammation in PDM and type 2 diabetic patients. The in vitro study proposed in the project will assist in identifying the molecular mechanisms by which whole red raspberry protect islet cells against oxidative stress, insulin resistance and loss of cell function.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes

Exclusion Criteria:

* hypoglycemic agents
* Pregnant or nursing a child
* chronic medication that does not have a stable dose for greater than one month
* anti-inflammatory medication
* inflammatory disease

Primary outcomes:
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: 2 weeks
measure: A high-sensitivity C-reactive protein (hs-CRP) measured in milligrams per liter
timeFrame: 2 weeks
Secondary outcomes:
measure: 3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank L Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02977806: Iron Long-Term Labelling Study Malawi
Official title: The Evaluation of Iron Metabolism Using a Novel Isotope Dilution Method in Malawian Children, Who Have Previously Participated in a Stable Isotope Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron Absorption
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Malawian children who ingested stable iron isotopes in the frame of a former iron absorption study.

Brief summary: Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections in sub-Saharan Africa, a region with a high prevalence of iron deficiency, making the assessment of iron balance and efficiency of iron intervention difficult. A new method allowing accurate measurement of long-term oral iron absorption and allowing the estimation of iron requirements is highly needed. Such a novel method to quantify iron absorption and requirements using isotope dilution measurements in children should be validated in the present prospective observational study by following-up a group of 49 children given a stable iron isotope in an earlier trial. We will request seven blood samples within 2 years (sampling every four months) from the participants which will allow us to measure isotopic dilution for estimating total oral iron absorption over these 24 months.


Eligibility criteria: Inclusion Criteria:

* Have participated in the original absorption study and the two follow-up samplings
* Signed written informed consent from the guardian to participate in the study

Exclusion Criteria:

* Long-term medication
* Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the guardian's statement or med-ical examination (health booklet))
* Blood losses (surgery, accident) or blood transfusion during the past 4 months before study start.
* Residence too far away (\> 2 hours by motorbike) from study location (Zomba)

Primary outcomes:
measure: iron isotope composition in blood
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: College of Medicine
Study officials:
affiliation: Human Nutrition Laboratory, ETH Zürich
name: Michael Zimmermann, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03374306: Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate
Official title: Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Myopia
Myopia control
Atropine
Electroretinogram
Multifocal Electroretinogram
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2017-12-15
Enrollment: 71
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: PREVENTION

Brief summary: Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.


Eligibility criteria: Inclusion Criteria:

* Age between 7 and 10 years
* Good general health and no family history of ocular diseases
* No current or history of epilepsy or asthma
* Myopia : -0.50 to -1.00 D (inclusive, both eyes)
* Astigmatism : ≤ 0.50 D
* No hyperopia, amblyopia or strabismus
* No reported ocular eye diseases or disorders
* No drug allergy

Primary outcomes:
measure: Annualized Changes in Refractive Error (SER)
timeFrame: 18 months
Secondary outcomes:
measure: Annualized Change in Axial Length
timeFrame: 18 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Optometry, Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Henry HL CHAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04799106: Community Based Strategies for Early Detection of Melanoma
Official title: A Pilot Feasibility Study of Community Based Strategies for Early Detection of Melanoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Melanoma
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2021-03-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 melanoma survivors drawn from the California Cancer Registry will be invited to participate in the study. Assuming a 20% response rate, approximately 40 individuals will be identified to participate in the study, including 20 in Southern California and 20 in Northern California. Participants will be invited to identify up to four friends or first-degree family members to also participate in the study, for a total of 200 participants.

Brief summary: The purpose of this study is to pilot the use of community education and digital dermatology to increase the early detection of curable melanomas.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* \>1mm lesion thickness with ulceration (T2b) or \>2mm lesion thickness (T3/T4)
* Low socioeconomic status (SES) Non-Latinx White individuals (according to Yost's index SES level based on a principal components analysis)
* Latinx individuals
* Individual resides in semi-rural area, including zip codes within Antelope Valley in Southern California and Salinas in Northern California
* Individual speaks and reads English or Spanish
* Voluntary willingness and comprehension to consent

Exclusion Criteria:

Exclusion criteria is stage 0, I, IV, or unstaged diagnosis, or any individual who does not meet the above stated eligibility criteria will be excluded from the study.

Primary outcomes:
measure: Completion of self and partner skin examinations
timeFrame: 3 months
measure: Completion of self and partner skin examinations
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cedars-Sinai
name: Robert Haile, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04922606: Great Saphenous Vein Anatomy at the Proximal Medial Thigh as a Potential Site for Rescue Venous Access
Official title: Great Saphenous Vein Anatomy at the Proximal Medial Thigh as a Potential Site for Rescue Venous Access
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anatomy of the GSV for Rescue Peripheral IV Access
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the anatomy of the great saphenous vein at the level of the medial thigh in the general population in an effort to categorize this as a reliable target vessel for rescue peripheral IV access.


Eligibility criteria: Inclusion Criteria:

- Pediatric and adult Emergency Department patients and employees of all ages from all areas of the emergency department or additional training sites staffed by emergency medicine residents.

Exclusion Criteria:

* Critically ill patients as determined by the Emergency Medicine consultant of record for the patient.
* Legs not accessible due to dressing, wounds, or other factors.
* Overlying cellulitis/soft tissue infection or injury.
* Patients that are prison inmates and patients/patient's surrogates who are unable to give verbal consent/assent.

Primary outcomes:
measure: Successful visualization of GSV
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tobias Kummer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00384306: Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease
Official title: Investigation of the Side Effects of Orally Administered Glucocorticoids. An Open Label Study to Investigate the Effects of Orally Administered Prednisolone on Bone Metabolism in Patients With COPD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
prednisolone
bone biopsy
tetracycline labelling
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: University of Cambridge
First posted: 2006-10-06
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to establish associations between blood and urine markers of bone metabolism with histomorphometric changes (changes in the actual bone structure) resulting from short term oral prednisolone treatment in patients with COPD (chronic obstructive pulmonary disease).


Eligibility criteria: Inclusion criteria:

* Females subjects must be unable to have children.
* BMI 19 - 29.9
* Non-smokers, ex-smokers or current light smokers (\<10 cigarettes/day)

Exclusion criteria:

* High blood pressure
* Other significant disease
* Use of certain medications (to be decided by the investigator)

Primary outcomes:
measure: Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline
timeFrame: All measured with and without 3 weeks dosing with oral prednisolone
Secondary outcomes:
measure: Pharmacokinetic measurements Bone structure and micro computer tomography of bone biopsies Biochemical markers of bone formation, bone break down and hormones
timeFrame: All measured with and without 3 weeks dosing with oral prednisolone
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: GSK Clinical Trials Call Centre
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06127706: Recognition of Second Twin. Second Training vs Naive Performer. PROMPT Mannequin
Official title: Second Training vs Naive Performer on Second Twin Delivery on Mannequin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Twin Vaginal Delivery Skills
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups randomized One with previous lecture and training, one without
Primary purpose: TREATMENT

Brief summary: Anterior foot identification in second twin delivery Two different population of resident in ObGyn Group 1 previous formal lecture on twin vaginal delivery followed by PROMPT mannequin scenario.

Group 2 naive residents

Detailed description: The present study is addressed to evidential skills in residents with and without previous specific didactical approach to twin vaginal delivery in identification of anterior fetal foot.

The two group are randomized by age, sex, seniority. Both the naive and the previous lecture groups are invited to scenario without knowing the intention to test their skills.

The time to reach, the number of attempts are recorded.

Eligibility criteria: Inclusion Criteria:

* residents in Ob Gyn

Exclusion Criteria:

* none

Primary outcomes:
measure: time to identify foot
timeFrame: 6 weeks after lecture
measure: number of attempt to identify foot
timeFrame: 6 weeks after lecture
Secondary outcomes:
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Claudio Celentano
state: Italia
Study officials:
References:
citation: Gauthier S, Jeanneteau P, Legendre G, Boulvais E, Collin R, Malo L, Rolland D, Courtin O, Thubert T, Winer N, Dochez V. Vaginal delivery of the second twin: A simulation program for residents in obstetrics and gynecology in a type III university maternity hospital. J Gynecol Obstet Hum Reprod. 2022 Oct;51(8):102434. doi: 10.1016/j.jogoh.2022.102434. Epub 2022 Jun 26.
citation: Desseauve D, Daelemans C, Farin A, Jauvion IBM, Ceccaldi PF; Prise en charge des Accouchements a Risque eT des Urgences Maternelles PARTUM teaching program. Internal podalic version of second twin: Improving feet identification using a simulation model. Eur J Obstet Gynecol Reprod Biol. 2022 Aug;275:9-11. doi: 10.1016/j.ejogrb.2022.05.036. Epub 2022 Jun 6.
citation: Celentano C, Prefumo F, Matarrelli B, Mastracchio J, Mauri S, Rosati M. Comparison of practice vs theory model training for vacuum-assisted delivery: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2023 Nov;290:109-114. doi: 10.1016/j.ejogrb.2023.09.024. Epub 2023 Sep 26.