louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03833492: UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps
Official title: Efficacy and Safety of Underwater vs. Conventional Endoscopic Mucosal Resection for the Treatment of Diminutive Non-pedunculated Colorectal Polyps：A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.


Eligibility criteria: Inclusion Criteria:

Patients age between 18-75 years old with non-pedunculated colonic polyps (measuring between 4 and 9mm), who willing to participate in this study.

Exclusion Criteria:

1. pregnancy,
2. inflammatory bowel disease,
3. familial polyposis
4. the use of anticoagulant therapy or antiplatelet therapy
5. the absence of informed patient consent.
6. Polyps showing signs of deep submucosal invasion

Primary outcomes:
measure: complete resection rate
timeFrame: 7 days
measure: En bloc resection rate
timeFrame: immediately
Secondary outcomes:
measure: Adverse event rate
timeFrame: 14 days
measure: Procedure time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China
state: Zhejiang
city: Ningbo
country: China
facility: Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
References:
citation: Zhang Z, Xia Y, Cui H, Yuan X, Wang C, Xie J, Tong Y, Wang W, Xu L. Underwater versus conventional endoscopic mucosal resection for small size non-pedunculated colorectal polyps: a randomized controlled trial : (UEMR vs. CEMR for small size non-pedunculated colorectal polyps). BMC Gastroenterol. 2020 Sep 23;20(1):311. doi: 10.1186/s12876-020-01457-y.
Clinical trial NCT02541292: Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD
Official title: Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Facioscapulohumeral Muscular Dystrophy 1a
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 10
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: Persons in Denmark diagnosed with FSHD is invited to the study.

Brief summary: Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs.

The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD.

Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.


Eligibility criteria: Inclusion Criteria:

* Confirmed FSHD

Exclusion Criteria:

* All contraindications for undergoing an MRI scan

Primary outcomes:
measure: Muscle inflammation
timeFrame: One MRI scan per subject (exam lasts approximately 60 min.)
measure: Muscle fat fraction
timeFrame: One MRI scan per subject (exam lasts approximately 60 min.)
Secondary outcomes:
measure: Muscle strength
timeFrame: One muscle strength test per subject (exam lasts approximately 60 min.)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center
Study officials:
References:
Clinical trial NCT02699892: Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis
Official title: Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving rituximab no longer than 4 weeks for the treatment of rheumatoid arthritis before the start of study.

Brief summary: This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). Protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab will be administered at the discretion of treating physician according to approved label.


Eligibility criteria: Inclusion Criteria:

-Participants receiving rituximab no longer than 4 weeks before the start of monitoring

Exclusion Criteria:

-Not Applicable

Primary outcomes:
measure: Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion
timeFrame: Baseline, 24 weeks after first rituximab infusion (Week 24)
Secondary outcomes:
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Good Response
timeFrame: Baseline, Weeks 24, 48 and 72
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: Niska Banja
country: Serbia
city: Nova sad
country: Serbia
city: Novi Sad
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01133392: Bioequivalence of Two Lispro Formulations
Official title: Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: insulin
lispro
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.

Detailed description: The 2 formulations of insulin lispro will be referred to here as:

Lispro A

Lispro B

Eligibility criteria: Inclusion Criteria:

* Are healthy males or females.
* Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m\^2)
* Are nonsmokers.
* Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

Exclusion Criteria:

* History of first-degree relatives known to have diabetes mellitus.
* Evidence of significant active neuropsychiatric disease.
* Evidence of an acute infection with fever or infectious disease.
* Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
* Have used systemic glucocorticoids within 3 months prior to entry into the study.
* Have donated blood of 1 unit or more within the last 3 months prior to study entry.
* Excessive alcohol intake
* Have a fasting venous blood glucose (FBG, plasma) \>6 millimoles/liter (mmol/L) at screening.
* Have positive hepatitis B surface antigen.

Primary outcomes:
measure: Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]
timeFrame: 0 up to 8 hours post dose
Secondary outcomes:
measure: Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]
timeFrame: 0 to 8 hours post dose
measure: Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
timeFrame: 0 to 8 hours post dose
measure: Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
timeFrame: 0 to 8 hours post dose
measure: Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)
timeFrame: 0 to 8 hours post dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01509092: Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole
Official title: Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Macular Hole
Keywords: traumatic macular hole
vitrectomy
observation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.

Detailed description: Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.

Eligibility criteria: Inclusion Criteria:

* closed globe injury
* identification of full-thickness macular hole by optical coherence tomography within one month after trauma

Exclusion Criteria:

* open globe injury
* coexistence of idiopathic macular hole
* severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage)
* combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis)
* coexistence of high myopia
* coexistence of choroidal rupture or subretinal hemorrhage within the diameter of 400μm from the center of the foveola
* coexistence of severe optic nerve injury (no light perception, positive afferent pupillary defect)

Primary outcomes:
measure: macular hole closure rate
timeFrame: 6 month after injury
Secondary outcomes:
measure: central foveal thickness
timeFrame: 6 month after hole closure
measure: length of inner-segment outer-segment junction defect
timeFrame: 6 month after hole closure
measure: final visual acuity
timeFrame: 6 month after hole closure
Other outcomes:
Locations:
city: Xingtai
country: China
facility: Eye Hospital of Hebei Province
state: Hebei
city: Weifang
country: China
facility: Weifang Eye Hospital
state: Shandong
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Medical College
state: Zhejiang
city: Beijing
country: China
facility: China - Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chongqing
country: China
facility: Southwest Eye hospital of Third Military Medical University
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University school of Medicine
Study officials:
affiliation: Peking University Third Hospital
name: Zhi-Zhong Ma, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04805892: Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.
Official title: Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test as Compared to Standard Testing Technique. Test Performed by a Professional Versus Self-collection and Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Mach-E B.V.
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on samples collected by a healthcare professional versus self-collection; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.


Eligibility criteria: Inclusion Criteria:

Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.

Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:

* Currently experiencing symptoms of COVID-19.
* Be clinically diagnosed or suspected to have COVID-19.
* Recent past (3 weeks) exhibited symptoms of COVID-19.
* Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Interacted with a COVID-19 positive individual.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria may not be enrolled in this study:

* Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Have a deviated nasal septum.
* Cognitively impaired individuals resulting in the inability to provide informed consent

Primary outcomes:
measure: Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.
timeFrame: 1 visit, up to 2 hours
Secondary outcomes:
measure: Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.
timeFrame: 1 visit, up to 2 hours
Other outcomes:
Locations:
city: Flushing
country: United States
facility: Mobile Covid Services LLC
state: New York
Study officials:
References:
Clinical trial NCT00419692: Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
Official title: An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for RLS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Restless Legs Syndrome
Keywords: pharmacokinetic,
RLS
formulation,
food effect,
controlled release for RLS,
SK&F101468,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.


Eligibility criteria: Inclusion criteria:

* Patients with a diagnosis of RLS
* Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
* Normal blood pressure pre-study
* Light smokers only (\<20/day)

Exclusion criteria:

* History of postural hypotension or faints
* Secondary RLS
* Patients who suffer from a primary sleep disorder other than RLS
* Patients diagnosed with movement disorders
* Patients with unstable medical conditions
* Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
* Patients with abnormal laboratory values
* Patients with hepatitis or HIV
* Patients who abuse alcohol or drugs
* Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa

Primary outcomes:
measure: Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration
timeFrame: dosing interval
Secondary outcomes:
measure: Time to attain the maximum plasma concentration Time taken for ropinirole concentration to fall to half initial value Incidence of adverse events Vital signs, ECG and clinical laboratory data As above, but for ropinirole metabolites
timeFrame: Time taken for ropinirole concentration to fall to half initial value
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: GSK Investigational Site
city: George
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03179592: VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography
Official title: VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography (VOLCANIC-CTA): A Prospective Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Keywords: Computed Tomography
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2017-06-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes 120 patients who present to radiology department for clinically indicated CCTA scan. In order to be included patients must meet all inclusion criteria and none of the exclusion criteria.

Brief summary: The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA).


Eligibility criteria: Inclusion Criteria:

1. Referred for a clinically indicated CCTA scan.
2. Subject must be 18 - 85 years of age.
3. Subject must provide written informed consent prior to any study-related procedures being performed.
4. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

   * By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
   * By surgical sterilization, or
   * Post-menopausal, with minimum one (1) year history without menses.
2. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.
3. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).
4. Subject has an acute psychiatric disorder.
5. Subject is unwilling to comply with the requirements of the protocol.
6. Subject has previously entered this study.
7. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
8. Subject has impaired renal function (creatinine \> 1.5 mg/dl).
9. Subject is in unstable condition.

Primary outcomes:
measure: Qualitative assessment of image quality
timeFrame: 2 years
measure: Quantitative assessment of image quality
timeFrame: 2 years
Secondary outcomes:
measure: Radiation dose of coronary CTA
timeFrame: 2 years
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT06581692: Non-invasive Monitoring of Miscarriage
Official title: Non-invasive Monitoring of Miscarriage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Miscarriage in First Trimester
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be approached on the day of attending the early pregnancy loss clinic, and given information about the study. Sufficient time will be allowed for consideration before they confirm their decision and sign the consent. For cases with the management of ultrasound-guided manual vacuum aspiration (USG-MVA) or surgical evacuation, their remaining products of gestation will be collected for analysis.

Brief summary: cfDNA is extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.

Detailed description: Pregnancies achieved by assisted reproductive technologies (ART) are closely monitored, therefore miscarriages that occur very early in the pregnancy are frequently meticulously recorded and reported. On the other hand, spontaneous abortion rates among naturally occurring conceptions are notoriously hard to quantify and are often overstated when using criteria from assisted reproductive technologies. Additionally, women who have undergone treatment with ART are a particular population with traits that can make them more vulnerable to spontaneous abortions.

cfDNA would be extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.

Eligibility criteria: Inclusion Criteria:

1. Age 18-45 years.
2. Women who attend the early pregnancy loss clinic or Patients who receive ART
3. Their partner, the biological father of the pregnancy

Exclusion Criteria:

* History of psychological/ psychiatric problem
* Patient refusal

Primary outcomes:
measure: Cell-free DNA (cfDNA)
timeFrame: 15 weeks
Secondary outcomes:
measure: Level of cell-free DNA
timeFrame: 15 weeks
measure: Aneuploidy results from product of conception
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: PUI WAH JACQUELINE CHUNG
role: PRINCIPAL_INVESTIGATOR
References: