louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00754819: Targeting Inflammation in Acute Coronary Syndrome Using Colchicine
Official title: Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Coronary Syndrome
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 80
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: The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.


Eligibility criteria: Inclusion Criteria:

* All patients with a diagnosis of acute coronary syndrome who are \> 18 years old and who do not have any contraindication to colchicine.

Exclusion Criteria:

* Contraindication to colchicine including any of the following:

  * hypersensitivity to colchicine
  * severe renal, hepatic or gastrointestinal disorder
  * blood dyscrasias (myelodysplasia cytopenias etc)
* Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol)
* Known severe liver disease and/or elevated transaminases \> 1.5x the upper limit of normal
* Estimated GFR \< 50 ml/min
* Pregnant or lactating women or women not protected by a reliable contraception method
* Current treatment with colchicine at enrollment
* Active infection or systemic inflammation eg active rheumatoid arthritis

Primary outcomes:
measure: To determine the effect of low dose colchicine on hs-CRP.
timeFrame: 30 days
Secondary outcomes:
measure: To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events
timeFrame: 30 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: John Eikelboom, FRACP FRCPA
role: STUDY_DIRECTOR
References:
Clinical trial NCT06725719: Translocator Protein PET/CT in Various TSPO-Related Disease
Official title: Translocator Protein PET/CT in Various TSPO-Related Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroinflammation
Stroke
Neurodegenerative Diseases
Keywords: PET/CT
MRI
TSPO
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2024-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled TSPO PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Brief summary: To evaluate the potential usefulness of 18F-DPA714/FDPA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various TSPO-related disease patients.

Detailed description: Subjects with various Tau-related disease patients underwent 18F-DPA714/FDPA PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-DPA714/FDPA PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled TSPO PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: Anhui
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04953819: Coronary Revascularization in Patients With Dialysis in China
Official title: Coronary RevascUlarization in Patients With End-stage Renal dIsease on dialysiS in China: a Nationwide and multicEnter Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Dialysis
Intervention
Keywords: dialysis
coronary artery disease
revascularization
optimal medical therapy
prognosis
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study will be selected from around 30 different hospitals in 7 different areas in China.

Brief summary: China patients in end stage renal disease receiving maintenance dialysis have a high risk of cardiovascular disease (CVD), with a prevalence of 45.5% approximately, and coronary artery disease (CAD) has been identified as the most common one. It remains unclear that what their treatment status is and whether this group of patients can benefit from revascularization in China. The investigators plan to recruit around 30 hospitals from 7 regions as study centers, which represent different levels of economic development in Mainland China. The detailed information includes demographics, medical history, coronary angiogram, in-hospital treatment and procedures, short-term and long-term outcomes. The aim of the study is to provide the real world knowledge about current status of coronary revascularization and prognosis in patients with CAD and dialysis.


Eligibility criteria: Inclusion Criteria:

* Aged 18 or above and 85 or below.
* Receives peritoneal dialysis or hemodialysis more than 1-time weekly and for more than 3 months.
* Diagnosed with coronary artery disease, including STEMI, NST-ACD, stable coronary artery disease.

Exclusion Criteria:

* Pregnancy or lactation.
* Can't be cooperative because of a mental illness or other reasons.
* Malignant tumor or severe hepatic disease.
* Life expectancy is less than 1 year.

Primary outcomes:
measure: Incidence of all-cause death
timeFrame: the duration of hospital stay, an expected average of 2 weeks
measure: Incidence of all-cause death and non-fatal myocardial infarction
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Incidence of all-cause death and non-fatal myocardial infarction
timeFrame: within 30 days after discharge
measure: Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization.
timeFrame: 12-month follow-up
measure: Incidence of bleeding
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jingang Zheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03851419: The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania
Official title: The Burden of (Neuro)Cysticercosis Among People Living With HIV Compared With HIV-negative Individuals in the Rural Southern Highlands in Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocysticercosis
HIV/AIDS
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
name: Kilimanjaro Clinical Research Institute
name: Muhimbili University of Health and Allied Sciences
First posted: 2019-02-22
Enrollment: 2584
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 patients from HIV clinics will be recruited at the study sites in Mbeya and Iringa region. For each HIV-positive patient an HIV-negative control matched by age, sex and location will be included.

Brief summary: This study aims to compare the burden of neurocysticercosis among people living with HIV to people not infected with HIV.

Detailed description: People living with HIV and matched HIV negative controls will be tested serologically for cysticercosis, examined neurologically and will undergo CT scanning to determine the prevalence and presentation of NCC.

Furthermore, the immune system response in HIV patients with Taenia solium neurocysticercosis will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients who consent to participate in the study and testing.
* Patients of age 14 years and above
* Patient living inside the study catchment area
* HIV-positive patients
* Patient suspected of taeniasis or cysticercosis/neurocysticercosis

Exclusion Criteria:

* Patients with opportunistic infections.
* Study participants taking anthelminthic drugs PZQ and ALB or have received them within the previous 12 months.
* Pregnant women
* Patients that are seriously ill.
* Patients with epilepsy and other mental disorders that impair thoughts and emotions such as psychosis.

Primary outcomes:
measure: Prevalence of cysticercosis
timeFrame: Single assessment at inclusion into study (serological testing)
measure: Prevalence of neurocysticercosis
timeFrame: Single assessment through cerebral CT scan at inclusion into study
Secondary outcomes:
measure: Th1 cytokines among neurocysticercosis patients
timeFrame: One time assessment through immunological testing at inclusion into study
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: National Institute of Medical Research
Study officials:
affiliation: National Institute for Medical Research
name: Bernard J Ngowi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02131519: Utility of Ultrasonography During Internal Jugular Vein Catheterisation in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Number of Trials
Complication Rate
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients aged more than 1 month

Brief summary: Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Obtaining central venous access in pediatric patients can be challenging, failure rates in pediatric patients range from 5% to 19% with reported complication rates from 2,5% to 22% The landmark technique has been standard approach for many years. In comparison with landmark method in pediatric patients the use of ultrasound is associated with an increased success rate decreased operative time, reduced number of cannulation attempts , and a decreased number of carotid artery punctures. We wanted to evaluate our success rate using ultrasound as a guidance during central vein insertion.


Eligibility criteria: Inclusion Criteria:

* pediatric patients required internal jugular vein catheter

Exclusion Criteria:

* aged smaller than 1 month

Primary outcomes:
measure: success rate
timeFrame: during anesthesia
Secondary outcomes:
measure: complication rate
timeFrame: during anesthesia
Other outcomes:
measure: effect of experience
timeFrame: during anesthesia
Locations:
city: Ankara
country: Turkey
facility: Ankara University, Pediatric Surgery
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References:
Clinical trial NCT02823119: Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Office Hysteroscopy
Official title: Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Diagnostic Office Hysteroscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain
Keywords: Mini-hysteroscopy
Office hysteroscopy
Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

Detailed description: The results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. Several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

Eligibility criteria: Inclusion Criteria:

* Nulliparous patients

Exclusion Criteria:

* Parous patients, menopausal status, cervical pathology, and previous cervical surgery

Primary outcomes:
measure: Intensity of pain
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Duration of procedure
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obstetrics and Gynecology Department,Cairo university
Study officials:
affiliation: Cairo University
name: Usama M Fouda, M.D, PhD
role: STUDY_DIRECTOR
References:
citation: Rullo S, Sorrenti G, Marziali M, Ermini B, Sesti F, Piccione E. Office hysteroscopy: comparison of 2.7- and 4-mm hysteroscopes for acceptability, feasibility and diagnostic accuracy. J Reprod Med. 2005 Jan;50(1):45-8.
Clinical trial NCT03423719: Evaluation of Fiit-ns® in Health-related Quality of Life Improvement in Overweight and Obese Subjects
Official title: Effect of a 16-week Supplementation With a Mediterranean Fruit and Vegetables Extract Rich in Polyphenols, Fiit-ns®, on Health-related Quality of Life of Overweight and Obese Volunteers: a Randomized, Double-blind, Parallel Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 92
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effects of a 16-week supplementation with a polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL) of overweight and obese volunteers, as compared to placebo. Previous beneficial results from a pilot study showed that the supplementation may improve quality of life as well as body composition. Based on such results, this pivotal study is statistically powered to detect significant differences in HR-QOL assessed with the Short Form-36 Health survey (SF-36) between baseline (Week 1, W1) and end of the supplementation period (Week 16, W16).


Eligibility criteria: Inclusion Criteria:

* 25 kg/m2 ≤ Body Mass Index (BMI) ≤ 40 kg/m2
* 25-55 years old

Exclusion Criteria:

* Metabolic and/or chronic disease (diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, asthma, anxiety, depression)
* Allergy to one of the ingredients of the supplement
* Current involvement of involvement within the 6 previous months in a chronic supplement program, chronic treatment program, weight loss program
* Smoking cessation
* High alcohol consumption
* Pregnancy
* Breastfeeding
* Menopausal women
* Involvement in physical activity more than twice a week

Primary outcomes:
measure: Change in health-related quality of life as assessed by the SF-36 Health Survey
timeFrame: Baseline (Week 1) and end of the supplementation period (Week 16)
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline (Week 1) and end of the supplementation period (Week 16)
measure: Change in waist circumference
timeFrame: Baseline (Week 1) and end of the supplementation period (Week 16)
measure: Change in total body fat mass
timeFrame: Baseline (Week 1) and end of the supplementation period (Week 16)
measure: Change in trunk fat mass
timeFrame: Baseline (Week 1) and end of the supplementation period (Week 16 )
measure: Change in physical activity level
timeFrame: Baseline (Week 1) and end of the supplementation period (Week 16)
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM (Universidad Catolica San Antonio de Murcia)
Study officials:
affiliation: UCAM (Universidad Catolica San Antonio de Murcia)
name: Pedro E Alcaraz Ramon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05668819: Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes
Official title: Open-Label, Randomized, Controlled, Parallel Group Study Evaluating Efficacy and Safety of Digital Therapeutic (TH-001) for the Treatment of Prediabetes in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: Prediabetic State
Digital Therapeutic
Mobile Health
Digital Health
Mobile Apps
Lifestyle Modification
mHealth
Lead sponsor: Tesu Saglik Teknolojileri A.S.
Sponsor class: INDUSTRY
First posted: 2022-12-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-Label, Randomized, Controlled
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with prediabetes according to the ADA Prediabetes Diagnostic Criteria (the presence of at least one of the following criteria is sufficient for diagnosis: FBG 100 - 125 mg/dL, OGTT 2 hour BG: 140 - 199 mg/dL, HbA1c: 5.7% - 6.4)
* Not using medication for the treatment of prediabetes, and if so, taking a break for at least two weeks
* Having a smartphone with an iOS or Android operating system
* Being able to use a mobile application

Exclusion Criteria:

* Being diagnosed with diabetes mellitus
* Having a disease that can cause prediabetes
* Taking medication that may cause prediabetes

Primary outcomes:
measure: Change in HbA1c
timeFrame: 90 days
measure: Change in FPG
timeFrame: 90 days
measure: Change in PPG
timeFrame: 90 days
Secondary outcomes:
measure: Change in weight
timeFrame: 90 days
measure: Change in BMI
timeFrame: 90 days
measure: Change in WC
timeFrame: 90 days
measure: Change in WHR
timeFrame: 90 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
Study officials:
affiliation: Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
name: Ramazan Cakmak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02037919: Nexplanon Application Post-Abortion (NAPA)
Official title: Immediate vs. Delayed Insertion of Nexplanon After Termination of Pregnancy Over 14-weeks Gestation (NAPA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Abortion, Therapeutic
Lead sponsor: Family Planning Associates Medical Group, LTD
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: The Cleveland Clinic
First posted: 2014-01-16
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Women who receive Nexplanon immediately post abortion will be significantly more likely to be using the device 6 months after the procedure than those assigned to receive the device 2-4 weeks after the procedure.

Detailed description: Women will be contacted 6 months after their abortion to ask about contraception use and side effects.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older,
* an intrauterine pregnancy \> 14 weeks and \<23 6/7 weeks gestation and desire termination of pregnancy
* desire a Nexplanon for contraception
* able to give informed consent in English
* no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D\&E

Exclusion Criteria:

* unable to give informed consent
* have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon.
* non-surgical management of pregnancy
* prior participation in this study
* breast cancer or a history of breast cancer

Primary outcomes:
measure: Intention-to-treat Analysis of Etonogestrel Implant Use
timeFrame: 6 months
measure: Per-protocol Analysis of Etonogestrel Implant Use
timeFrame: 6 months
Secondary outcomes:
measure: Repeat Pregnancy
timeFrame: 6 months
Other outcomes:
measure: Implant Inserted
timeFrame: Within 4 weeks of abortion
measure: Completed 6-month Phone Call
timeFrame: 6 months
Locations:
city: Chicago
country: United States
facility: Family Planning Associates Medical Grooup, LTD
state: Illinois
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Miriam Cremer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: